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Full text of "North Carolina Register v.7 no. 19 (1/4/1993)"

/\ .fl- ^ f\ ' ' / ' J ' I ' ' / 



The 
NORTH CAROLINA 



it 



REGISTER 



IN THIS ISSUE 




GENERAL STATUTES 

EXECUTIVE ORDER 

IN ADDITION 

Wildlife Resources Commission Proclamation 

PROPOSED RULES 

Environment, Health, and Natural Resources 
Human Resources 
Mortuary Science, Board of 
Safety and Health Review Board 

RRC OBJECTIONS 

RULES INVALIDATED BY JUDICIAL DECISION 

RECEIVED 
CONTESTED CASE DECISIONS 

JAN 7 1993 

ISSUE DATE: January 4, 1993 

LAW LIBRARY 

Volume 7 • Issue 19 • Pages 2060 - 2215 



INFORMATION ABOUT THE NORTH CAROLINA REGISTER AND ADMINISTRATIVE CODE 



NORTH CAROLINA REGISTER 



TEMPORARY RULES 



The North Carolina Register is published twice a month and 
contains information relating to agency, executive, legislative and 
judicial actions required by or affecting Chapter 150B of the 
General Statutes. All proposed administrative rules and notices of 
public hearings filed under G.S. 150B-21.2 must be published in 
the Register. The Register will typically comprise approximately 
fifty pages per issue of legal text. 

State law requires that a copy of each issue be provided free of 
charge to each county in the state and to various state officials and 
ins ti nations. 

The North Carolina Register is available by yearly subscription 
at a cost of one hundred and five dollars (S105.00) for 24 issues. 
Individual issues may be purchased for eight dollars (S8.00). 

Requests for subscription to the North Carolina Register should 
be directed to the Office of Administrative Hearings, 
P. 0. Drawer 27447, Raleigh, N. C. 2761 1-7447. 



Under certain emergency conditions, agencies may issue 
temporary rules. Within 24 hours of submission to OAH, the 
Codifier of Rules must review the agency's written statement of 
findings of need for the temporary rule pursuant to the provisions in 
G.S. 150B-21.1. If the Codifier determines that the findings meet 
the criteria in G.S. 150B-21.1, the rule is entered into the NCAC. If 
the Codifier determines that the findings do not meet the criteria, 
the rule is returned to the agency. The agency may supplement its 
findings and resubmit the temporary rule for an additional review 
or the agency may respond that it will remain with its initial 
position. The Codifier, thereafter, will enter the rule into the 
NCAC. A temporary rule becomes effective either when the 
Codifier of Rules enters the rule in the Code or on the sixth 
business day after the agency resubmits the rule without change. 
The temporary rule is in effect for the period specified in the rule or 
180 days, whichever is less. An agency adopting a temporary rule 
must begin rule-making procedures on the permanent rule at the 
same time the temporary rule is filed with the Codifier. 



ADOPTION AMENDMENT, AND REPEAL OF 
RULES 



NORTH CAROLINA ADMINISTRATIVE CODE 



The following is a generalized statement of the procedures to be 
followed for an agency to adopt, amend, or repeal a rule. For the 
specific statutory authority, please consult Article 2A of Chapter 
150B of the General Statutes. 

Any agency intending to adopt, amend, or repeal a rule must 
first publish notice of the proposed action in the North Carolina 
Register. The notice must include the time and place of the public 
hearing (or instructions on how a member of the public may request 
a hearing); a statement of procedure for public comments; the text 
of the proposed rule or the statement of subject matter; the reason 
for the proposed action; a reference to the statutory authority for the 
action and the proposed effective date. 

Unless a specific statute provides otherwise, at least 15 days 
must elapse following publication of the notice in the North 
Carolina Register before the agency may conduct the public 
hearing and at least 30 days must elapse before the agency can take 
action on the proposed rule. An agency may not adopt a rule that 
differs substantially from the proposed form published as part of 
the public notice, until the adopted version has been published in 
the North Carolina Register for an additional 30 day comment 
period. 

When final action is taken, the promulgating agency must file 
the rule with the Rules Review Commission (RRC). After approval 
by RRC, the adopted rule is filed with the Office of Administrative 
Hearings (OAH). 

A rule or amended rule generally becomes effective 5 business 
days after the rule is filed with the Office of Administrative 
Hearings for publication in the North Carolina Administrative Code 
(NCAC). 

Proposed action on rules may be withdrawn by the promulgating 
agency at any time before final action is taken by the agency or 
before filing with OAH for publication in the NCAC. 



The North Carolina Administrative Code (NCAC) is a 
compilation and index of the administrative rules of 25 state 
agencies and 38 occupational licensing boards. The NCAC 
comprises approximately 15,000 letter size, single spaced pages of 
material of which approximately 35% of is changed annually. 
Compilation and publication of the NCAC is mandated by G.S. 
150B-21.18. 

The Code is divided into Titles and Chapters. Each state agency 
is assigned a separate title which is further broken down by 
chapters. Title 21 is designated for occupational licensing boards. 

The NCAC is available in two formats. 

(1) Single pages may be obtained at a minimum cost of 
two dollars and 50 cents (S2.50) for 10 pages or less, 
plus fifteen cents (SO. 15) per each additional page. 

(2) The full publication consists of 53 volumes, totaling in 
excess of 15,000 pages. It is supplemented monthly 
w-ith replacement pages. A one year subscription to the 
full publication including supplements can be 
purchased for seven hundred and fifty dollars 
(S750.00). Individual volumes may also be purchased 
with supplement service. Renewal subscriptions for 
supplements to the initial publication are available. 

Requests for pages of rules or volumes of the NCAC should be 
directed to the Office of Administrative Hearings. 



CITATION TO THE NORTH CAROLINA 
REGISTER 

The North Carolina Register is cited by volume, issue, page 
number and date. 1:1 NCR 101-201, April 1, 1986 refers to 
Volume 1, Issue 1, pages 101 through 201 of the North Carolina 
Register issued on April 1, 1986. 



FOR INFORMATION 


CONTACT 


Office 


of 


Administrative Hearin 


gs. 


ATTN: Rules 


Division, 


P.O. 


Drawer 27447, Raleigh, 


North Carolina 27611-7447, 


(919) 


733-2678. 











NORTH 
CAROLINA 
REGISTER 




Office of Administrative Hearings 

P. O. Drawer 27447 

Raleigh, North Carolina 27611-7447 

(919) 733-2678 



Julian Mann III, 

Director 
James R. Scarcella St., 

Deputy Director 
Molly Masich, 

Director of APA Services 



Staff: 

Ruby Creech, 

Publications Coordinator 
Teresa Kilpatrick, 

Editorial Assistant 
Jean Shirley, 

Editorial Assistant 



ISSUE CONTENTS 



I. GENERAL STATUTES 

Chapter 150B 2060 

II. EXECUTIVE ORDER 

Executive Order 183 2081 

III. IN ADDITION 

Wildlife Resources Commission 
Proclamation 2082 

IV. PROPOSED RULES 
Environment, Health, and 

Natural Resources 

Environmental Management .... 2086 

Health Services 2141 

Radiation Protection 2087 

Human Resources 
Medical Assistance 2083 

Independent Agencies 
Safety and Health Review 

Board 2190 

Licensing Board 
Mortuary Science 2184 

V. RRC OBJECTIONS 2193 

VI. RULES INVALIDATED BY 

JUDICIAL DECISION 2198 

VII. CONTESTED CASE DECISIONS 

Index to ALI Decisions 2199 

Text of Selected Decisions 

92 DST 0686 2201 

92 DHR 0853 2205 

VIII. CUMULATIVE INDEX 2213 



NORTH CAROLINA REGISTER 

Publication Schedule 

(August 1992 - December 1993) 







Last Day 


Earliest 


Earliest 










for Elec- 


Date for 


Date for 


Last Day 


^Earliest 


Issue 


Last Day 


tronic 


Public 


Adoption 


to Submit 


Effective 


Date 


for Filing 


riling 


Hearing 


by Agency 


to RRC 


Date 


>k sk^i >k ■Jf. sj; >■< 


******* 


>< ■>< £: ?k >k & ik 


******* 


******* 


******* 


******* 


08/03/92 


07/13/92 


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08/18/92 


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Tlie "Earliest Effective Date" is computed assuming that the agency follows the 
publication schedule above, that the Rules Review Commission approves the ride at 
the next calendar month meeting after submission, and that RRC delivers the rule to 
the Codifier of Rules five (5) business days before the 1st business day of the next 
calendar month. 



GENERAL STATUTES OF NORTH CAROLINA 



CHAPTER 150B 

THE ADMINISTRATIVE PROCEDURE ACT 

[The following excerpt contains the statutory provisions of the Administrative Procedure Act as amended by 
the 1991 General Assembly, Second Session effective July 1. 1992 and January 1. 1993.] 



Article 1. 
General Provisions. 
§ 150B-1. Policy and scope. 

(a) Purpose. — This Chapter establishes a uni- 
form system of administrative rule making and 
adjudicatory procedures for agencies. The proce- 
dures ensure that the functions of rule making, 
investigation, advocacy, and adjudication are not 
all performed by the same person in the adminis- 
trative process. 

(b) Rights. — This Chapter confers procedural 
rights. 

(c) Full Exemptions. — This Chapter applies to 
every agency except: 

(1) The North Carolina National Guard in 
exercising its court-martial jurisdiction. 

(2) The Department of Human Resources 
in exercising its authority over the 
Camp Butner reservation granted in 
Article 6 of Chapter 122C of the Gen- 
eral Statutes. 

(3) The Utilities Commission. 

(4) The Industrial Commission. 

(5) The Employment Security Commission. 

(d) Exemptions From Rule Making. — Article 
2A of this Chapter does not apply to the following: 

(1) The Commission. 

(2) The North Carolina Low-Level Radio- 
active Waste Management Authority in 
administering the provisions of G.S. 
104G-10 and G.S. 104G-1 1. 

(3) The North Carolina Hazardous Waste 
Management Commission in administer- 
ing the provisions of G.S. 130B-13 and 
G.S. 130B-14. 

(4) The Department of Revenue, except 
that Parts 3 and 4 of Article 2A apply 
to the Department. 

(5) The North Carolina Air Cargo Airport 
Authority with respect to the acquisi- 
tion, construction, operation, or use. 
including fees or charges, of any por- 
tion of a cargo airport complex. 

(e) Exemptions From Contested Case Provi- 
sions. -- The contested case provisions of this 
Chapter apply to all agencies and all proceedings 
not expressly exempted from the Chapter. The 



contested case provisions of this Chapter do not 
apply to the following: 

(1) The Department of Human Resources 
and the Department of Environment, 
Health, and Natural Resources in com- 
plying with the procedural safeguards 
mandated by Section 680 of Part H of 
Public Law 99-457 as amended (Educa- 
tion of the Handicapped Act Amend- 
ments of 1986). 

(2) The Governors Waste Management 
Board in administering the provisions of 
G.S. 104E-6.2 and G.S. 130A-293. 

(3) The North Carolina Low-Level Radio- 
active Waste Management Authority in 
administering the provisions of G.S. 
104G-9, 104G-10. and 104G-11. 

(4) The North Carolina Hazardous Waste 
Management Commission in administer- 
ing the provisions of G.S. 130B-11. 
130B-13, and 130B-14. 

(5) Hearings required pursuant to the Reha- 
bilitation Act of 1973. (Public Law 
93-122), as amended and federal regu- 
lations promulgated thereunder. G.S. 
150B-51(a) is considered a contested 
case hearing provision that does not 
apply to these hearings. 

(6) The Department of Revenue. 

(7) The Department of Correction. 

(8) The Department of Transportation, 
except as provided in G.S. 136-29. 

(9) The Occupational Safety and Health 
Review Board in all actions that do not 
involve agricultural employers. 

(10) The North Carolina Air Cargo Airport 
Authority with respect to the acquisi- 
tion, construction, operation, or use. 
including fees or charges, of any por- 
tion of a cargo airport complex. 

(f) Exemption From All But Judicial Review. — 
No Article in this Chapter except Article 4 applies 
to the University of North Carolina. 
§ 150B-2. Definitions. — As used in this 

Chapter. 

(01) "Administrative law judge" means a 
person appointed under G.S. 7A-752. 



7:19 



NORTH CAROLINA REGISTER 



January 4, 1993 



2060 



GENERAL STATUTES OF NORTH CAROLINA 



7A-753. or 7A-757. 

(1) "Agency" means an agency or an offi- 
cer in the executive branch of the gov- 
ernment of this State and includes the 
Council of State, the Governor's Of- 
fice, a board, a commission, a depart- 
ment, a division, a council, and any 
other unit of government in the execu- 
tive branch. A local unit of govern- 
ment is not an agency. 

(la) "Adopt" means to take final action to 
create, amend, or repeal a rule. 

(lb) "Codifier of Rules" means the Chief 
Administrative Law Judge of the Office 
of Administrative Hearings or a desig- 
nated representative of the Chief Ad- 
ministrative Law Judge. 

(lc) "Commission" means the Rules Review 
Commission. 

(2) "Contested case" means an administra- 
tive proceeding pursuant to this Chapter 
to resolve a dispute between an agency 
and another person that involves the 
person's rights, duties, or privileges, 
including licensing or the levy of a 
monetary penalty. "Contested case" 
does not include rulemaking, declarato- 
ry' rulings, or the award or denial of a 
scholarship or grant. 

(2a) Repealed. 

(2b) "Hearing officer" means a person or 
group of persons designated by an 
agency that is subject to Article 3A of 
this Chapter to preside in a contested 
case hearing conducted under that Arti- 
cle. 

(3) "License" means any certificate, permit 
or other evidence, by whatever name 
called, of a right or privilege to engage 
in any activity, except licenses issued 
under Chapter 20 and Subchapter I of 
Chapter 105 of the General Statutes and 
occupational licenses. 

(4) "Licensing" means any administrative 
action issuing, failing to issue, suspend- 
ing, or revoking a license or occupa- 
tional license. "Licensing" does not 
include controversies oxer whether an 
examination was fair or whether the 
applicant passed the examination. 

(4a) Occupational license" means any certifi- 
cate, permit, or other evidence, by 
whatever name called, of a right or 
privilege to engage in a profession, 
occupation, or field of endeavor that is 



issued by an occupational licensing 
agency. 
(4b) "Occupational licensing agency" means 
any board, commission, committee or 
other agency of the State of North 
Carolina which is established for the 
primary purpose of regulating the entry 
of persons into, and/or the conduct of 
persons within a particular profession, 
occupation or field of endeavor, and 
which is authorized to issue and revoke 
licenses. "Occupational licensing agen- 
cy" does not include State agencies or 
departments which may as only a part 
of their regular function issue permits 
or licenses. 

(5) "Party" means any person or agency 
named or admitted as a party or proper- 
ly seeking as of right to be admitted as 
a party and includes the agency as 
appropriate. This subdivision does not 
permit an agency that makes a final 
decision, or an officer or employee of 
the agency, to petition for initial judi- 
cial review of that decision. 

(6) "Person aggrieved" means any person 
or group of persons of common interest 
directly or indirectly affected substan- 
tially in his or its person, property, or 
employment by an administrative deci- 
sion. 

(7) "Person" means any natural person, 
partnership, corporation, body politic 
and any unincorporated association, 
organization, or society which may sue 
or be sued under a common name. 

(8) "Residence" means domicile or princi- 
pal place of business. 

(8a) "Rule" means any agency regulation. 
standard, or statement of general appli- 
cability that implements or interprets an 
enactment of the General Assembly or 
Congress or a regulation adopted by a 
federal agency or that describes the 
procedure or practice requirements of 
an agency. The term includes the 
establishment of a fee and the amend- 
ment or repeal of a prior rule. The 
term does not include the following: 
a. Statements concerning only the 
internal management of an agency 
or group of agencies within the 
same principal office or depart- 
ment enumerated in G.S. 143-11 
or 143B-6. including policies and 



2061 



7:19 



NORTH CAROLINA REGISTER 



Januan 4, 1993 



GENERAL STATUTES OF NORTH CAROLINA 



procedures manuals, if the state- 
ment does not directly or substan- 
tially affect the procedural or 
substantive rights or duties of a 
person not employed by the agen- 
cy or group of agencies. 

b. Budgets and budget policies and 
procedures issued by the Director 
of the Budget, by the head of a 
department, as defined by G.S. 
143A-2 or G.S. 143B-3. by an 
occupational licensing board, as 
defined by G.S. 93B-1. or by the 
State Board of Elections. 

c. Nonbinding interpretive state- 
ments within the delegated author- 
ity of an agency that merely 
define, interpret, or explain the 
meaning of a statute or rule. 

d. A form, the contents or substan- 
tive requirements of which are 
prescribed by rule or statute. 

e. Statements of agency policy made 
in the context of another proceed- 
ing, including: 

1 . Declaratory rulings under G.S. 
150B-4. 

2. Orders establishing or fixing 
rates or tariffs. 

f. Requirements, communicated to 
the public by the use of signs or 
symbols, concerning the use of 
public roads, bridges, ferries, 
buildings, or facilities. 

g. Statements that set forth criteria 
or guidelines to be used by the 
staff of an agency in performing 
audits, investigations, or inspec- 
tions: in settling financial disputes 
or negotiating financial arrange- 
ments; or in the defense, prosecu- 
tion, or settlement of cases. 

h. Scientific, architectural, or engi- 
neering standards, forms, or 
procedures, including design 
criteria and construction standards 
used to construct or maintain 
highways, bridges, or ferries. 

i. Job classification standards, job 

qualifications, and salaries estab- 
lished for positions under the 
jurisdiction of the State Personnel 
Commission. 

j. Establishment of the interest rate 

that applies to tax assessments 



under G.S. 105-241.1 and the 
variable component of the excise 
tax on motor fuel under G.S. 
105-434. 
(8b) "Substantial evidence" means relevant 
evidence a reasonable mind might 
accept as adequate to support a con- 
clusion. 
(9) Repealed. 
§ 150B-3. Special provisions on licensing. 

(a) When an applicant or a licensee makes a 
timely and sufficient application for issuance or 
renewal of a license or occupational license, 
including the payment of any required license fee, 
the existing license or occupational license does 
not expire until a decision on the application is 
finally made by the agency, and if the application 
is denied or the terms of the new license or occu- 
pational license are limited, until the last day for 
applying for judicial review of the agency order. 
This subsection does not affect agency action 
summarily suspending a license or occupational 
license under subsections (b) and (c) of this sec- 
tion. 

(b) Before the commencement of proceedings 
for the suspension, revocation, annulment, with- 
drawal, recall, cancellation, or amendment of any 
license other than an occupational license, the 
agency shall give notice to the licensee, pursuant 
to the provisions of G.S. 150B-23. Before the 
commencement of such proceedings involving an 
occupational license, the agency shall give notice 
pursuant to the provisions of G.S. 150B-38. In 
either case, the licensee shall be given an opportu- 
nity to show compliance with all lawful require- 
ments for retention of the license or occupational 
license. 

(c) If the agency finds that the public health, 
safety, or welfare requires emergency action and 
incorporates this finding in its order, summary 
suspension of a license or occupational license may 
be ordered effective on the date specified in the 
order or on service of the certified copy of the 
order at the last known address of the licensee, 
whichever is later, and effective during the pro- 
ceedings. The proceedings shall be promptly 
commenced and determined. 

Nothing in this subsection shall be construed as 
amending or repealing any special statutes, in 
effect prior to February 1. 1976, which provide 
for the summary suspension of a license. 
§ 150B-4. Declaratory rulings. 

(a) On request of a person aggrieved, an agency 
shall issue a declaratory ruling as to the validity of 
a rule or as to the applicability to a given state of 



7:19 



NORTH CAROLINA REGISTER 



January 4, 1993 



2062 



GENERAL STATUTES OF NORTH CAROLINA 



facts of a statute administered by the agency or of 
a rule or order of the agency, except when the 
agency for good cause finds issuance of a ruling 
undesirable. The agency shall prescribe in its 
rules the circumstances in which rulings shall or 
shall not be issued. A declaratory ruling is bind- 
ing on the agency and the person requesting it 
unless it is altered or set aside by the court. An 
agency may not retroactively change a declaratory 
ruling, but nothing in this section prevents an 
agency from prospectively changing a declaratory' 
ruling. A declaratory ruling is subject to judicial 
review in the same manner as an order in a con- 
tested case. Failure of the agency to issue a 
declaratory ruling on the merits within 60 days of 
the request for such ruling shall constitute a denial 
of the request as well as a denial of the merits of 
the request and shall be subject to judicial review. 
(b) This section does not apply to the Depart- 
ment of Correction. 

Article 2. 
Rule Making. 

Repealed. 

Article 2A. 
Rules. 
Part 1. General Provisions. 
§ 150B-18. Scope and effect. 

This Article applies to an agency's exercise of its 
authority to adopt a rule. A rule is not valid 
unless it is adopted in substantial compliance with 
this Article. 

§ 150B-19. Restrictions on what can be adopt- 
ed as a rule. 

An agency may not adopt a rule that does one or 
more of the following: 

( 1 ) Implements or interprets a law unless 
that law or another law specifically 
authorizes the agency to do so. 

(2) Enlarges the scope of a profession, 
occupation, or field of endeavor for 
which an occupational license is re- 
quired. 

(3) Imposes criminal liability or a civil 
penalty for an act or omission, includ- 
ing the violation of a rule, unless a law 
specifically authorizes the agency to do 
so or a law declares that violation of 
the rule is a criminal offense or is 
grounds for a civil penalty. 

(4) Repeats the content of a law, a rule, or 
a federal regulation. 

(5) Establishes a reasonable fee or other 
reasonable charge for providing a ser- 
vice in fulfillment of a duty unless a 



law specifically authorizes the agency 
to do so or the fee or other charge is 
for one of the following: 

a. A service to a State, federal, or local 
governmental unit. 

b. A copy of part or all of a State publi- 
cation or other document, the cost of 
mailing a document, or both. 

c. A transcript of a public hearing. 

d. A conference, workshop, or course. 

e. Data processing services. 

(6) Allows the agency to waive or modify 
a requirement set in a rule unless a rule 
establishes specific guidelines the agen- 
cy must follow in determining whether 
to waive or modify the requirement. 

§ 150B-20. Petitioning an agency to adopt a 

rule. 

(a) Petition. -- A person may petition an agency 
to adopt a rule by submitting to the agency a 
written rule-making petition requesting the adop- 
tion. A person may submit written comments with 
a rule-making petition. If a rule-making petition 
requests the agency to create or amend a rule, the 
person must submit the proposed text of the 
requested rule change and a statement of the effect 
of the requested rule change. Each agency must 
establish by rule the procedure for submitting a 
rule-making petition to it and the procedure the 
agency follows in considering a rule-making 
petition. 

(b) Time. — An agency must grant or deny a 
rule-making petition submitted to it within 30 days 
after the date the rule-making petition is submitted, 
unless the agency is a board or commission. If the 
agency is a board or commission, it must grant or 
deny a rule-making petition within 120 days after 
the date the rule-making petition is submitted. 

(c) Action. -- If an agency denies a rule-making 
petition, it must send the person who submitted the 
petition a written statement of the reasons for 
denying the petition. If an agency grants a 
rule-making petition, it must inform the person 
who submitted the rule-making petition of its 
decision and must initiate rule-making proceedings. 
When an agency grants a rule-making petition 
requesting the creation or amendment of a rule, the 
notice of rule making it publishes in the North 
Carolina Register may state that the agency is 
initiating rule-making proceedings as the result of 
a rule-making petition, state the name of the 
person who submitted the rule-making petition, set 
out the text of the requested rule change submitted 
with the rule-making petition, and state whether 
the agency endorses the proposed rule change. 



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(d) Review. — Denial of a rule-making petition 
is a final agency decision and is subject to judicial 
review under Article 4 of this Chapter. Failure of 
an agency to grant or deny a rule-making petition 
within the time limits set in subsection (b) is a 
denial of the rule-making petition. 

(e) Exception. — This section does not apply to 
the Department of Correction. 

§ 150B-21. Agency must designate 

rule-making coordinator. 

Each agency must designate one or more 
rule-making coordinators to oversee the agency's 
rule-making functions. The coordinator must 
prepare notices of public hearings, coordinate 
access to the agency's rules, and serve as the 
liaison between the agency, other agencies, and the 
public in the rule-making process. 

Part 2. Adoption of Rules. 
§ 150B-21.1. Procedure for adopting a tem- 
porary rule. 

(a) Adoption. — An agency may adopt a tempo- 
rary rule without prior notice or hearing or upon 
any abbreviated notice or hearing the agency finds 
practical when it finds that adherence to the notice 
and hearing requirements of this Part would be 
contrary to the public interest and that the immedi- 
ate adoption of the rule is required by one or more 
of the following: 

( 1 ) A serious and unforeseen threat to the 
public health, safety, or welfare. 

(2) The effective date of a recent act of the 
General Assembly or the United States 
Congress. 

(3) A recent change in federal or State 
budgetary policy. 

(4) A federal regulation. 

(5) A court order. 

(6) The need for the rule to become effec- 
tive the same date as the State Medical 
Facilities Plan approved by the Gover- 
nor, if the rule addresses a matter 
included in the State Medical Facilities 
Plan. 

An agency must prepare a written statement of 
its findings of need for a temporary rule. The 
statement must be signed by the head of the agen- 
cy adopting the rule. 

An agency must begin rule-making proceedings 
for a permanent rule by the day it adopts a tempo- 
rary rule. An agency begins rule-making proceed- 
ings for a permanent rule by submitting to the 
codifier written notice of its intent to adopt a 
permanent rule. 

(b) Review. — When an agency adopts a tempo- 
rary rule it must submit the rule, the agency's 



written statement of its findings of need for the 
rule, and the notice of intent to adopt a permanent 
rule to the Codifier of Rules. Within one business 
day after an agency submits a temporary rule, the 
Codifier of Rules must review the agency's written 
statement of findings of need for the rule to deter- 
mine whether the statement of need meets the 
criteria listed in subsection (a). In reviewing the 
statement, the Codifier of Rules may consider any 
information submitted by the agency or another 
person. If the Codifier of Rules finds that the 
statement meets the criteria, the Codifier of Rules 
must notify the head of the agency and enter the 
rule in the North Carolina Administrative Code. 

If the Codifier of Rules finds that the statement 
does not meet the criteria, the Codifier of Rules 
must immediately notify the head of the agency. 
The agency may supplement its statement of need 
with additional findings or submit a new statement. 
If the agency provides additional findings or 
submits a new statement, the Codifier of Rules 
must review the additional findings or new state- 
ment within one business day after the agency 
submits the additional findings or new statement. 
If the Codifier of Rules again finds that the state- 
ment does not meet the criteria listed in subsection 
(a), the Codifier of Rules must immediately notify 
the head of the agency. 

If an agency decides not to provide additional 
findings or submit a new statement when notified 
by the Codifier of Rules that the agency's findings 
of need for a rule do not meet the required crite- 
ria, the agency must notify the Codifier of Rules 
of its decision. The Codifier of Rules must then 
enter the rule in the North Carolina Administrative 
Code on the sixth business day after receiving 
notice of the agency's decision. 

(c) Standing. -- A person aggrieved by a tempo- 
rary rule adopted by an agency may file an action 
for declaratory judgment in Wake County Superior 
Court pursuant to Article 26 of Chapter 1 of the 
General Statutes. In the action, the court shall 
determine whether the agency's written statement 
of findings of need for the rule meets the criteria 
listed in subsection (a) and whether the rule meets 
the standards in G.S. 150B-21.9 that apply to 
review of a permanent rule. The court may not 
grant an ex parte temporary restraining order. 

Filing a petition for rule making or a request for 
a declaratory ruling with the agency that adopted 
the rule is not a prerequisite to filing an action 
under this subsection. A person who files an 
action for declaratory judgment under this subsec- 
tion must serve a copy of the complaint on the 
agency that adopted the rule being contested, the 



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GENERAL STATUTES OF NORTH CAROLINA 



Codifier of Rules, and the Commission. 

(d) Effective Date and Expiration. -- A tempo- 
rary rule becomes effective on the date specified in 
G.S. 150B-21.3. A temporary rule expires on the 
date specified in the rule or 180 days from the date 
the rule becomes effective, whichever comes first. 
§ 150B-21.2. Procedure for adopting a per- 
manent rule. 

(a) Notice. -- Before an agency adopts a perma- 
nent rule, it must publish notice of its intent to 
adopt a permanent rule in the North Carolina 
Register and as required by any other law. The 
notice published in the North Carolina Register 
must include all of the following: 

( 1 ) Either the text of the proposed rule or 
a statement of the subject matter of the 
proposed rule making. 

(2) A short explanation of the reason for 
the proposed action. 

(3) A citation to the law that gives the 
agency the authority to adopt the pro- 
posed rule, if the notice includes the 
text of the proposed rule, or a citation 
to the law that gives the agency the 
authority to adopt a rule on the subject 
matter of the proposed rule making, if 
the notice includes only a statement of 
the subject matter of the proposed rule 
making. 

(4) The proposed effective date of the 
proposed rule, if the notice includes the 
text of the proposed rule, or the pro- 
posed effective date of a rule adopted 
on the subject matter of the proposed 
rule making, if the notice includes only 
a statement of the subject matter of the 
proposed rule making. 

(5) The date. time, and place of any public 
hearing scheduled on the proposed rule 
or subject matter of the proposed rule 
making. 

(6) Instructions on how a person may 
demand a public hearing on a proposed 
rule if the notice does not schedule a 
public hearing on the proposed rule and 
subsection (c) requires the agency to 
hold a public hearing on the proposed 
rule when requested to do so. 

(7) The period of time during which and 
the person to whom written comments 
may be submitted on the proposed rule 
or subject matter of the proposed rule 
making 

(8) If a fiscal note has been prepared for 
the proposed rule or will be prepared 



when a rule is proposed on the subject 

matter of the proposed rule making, a 

statement that a copy of the fiscal note 

can be obtained from the agency. 

(b) Mailing List. -- An agency must maintain a 

mailing list of persons who have requested notice 

of rule making. When an agency publishes a 

rule-making notice in the North Carolina Register, 

it must mail a copy of the notice to each person on 

the mailing list who has requested notice of 

rule-making proceedings on the rule or the subject 

matter for rule making described in the notice. An 

agency may charge an annual fee to each person 

on the agency's mailing list to cover copying and 

mailing costs. 

(c) Hearing. — An agency must hold a public 
hearing on a rule it proposes to adopt in two 
circumstances and may hold a public hearing in 
other circumstances. When an agency is required 
to hold a public hearing on a proposed rule or 
decides to hold a public hearing on a proposed rule 
when it is not required to do so. the agency must 
publish in the North Carolina Register a notice of 
the date. time, and place of the public hearing. 
The hearing date of a public hearing held after the 
agency publishes notice of the hearing in the North 
Carolina Register must be at least 15 days after the 
date the notice is published. 

An agency must hold a public hearing on a rule 
it proposes to adopt in the following two circum- 
stances: 

( 1 ) The agency publishes a statement of the 
subject matter of the proposed rule 
making in the notice in the North Caro- 
lina Register. 

(2) The agency publishes the text of the 
proposed rule in the notice in the North 
Carolina Register and all the following 
apply: 

a. The notice does not schedule a public 
hearing on the proposed rule. 

b. Within 15 days after the notice is 
published, the agency receives a 
written request for a public hearing on 
the proposed rule. 

c. The proposed rule is not part of a 
rule-making proceeding the agency 
initiated by publishing a statement of 
the subject matter of proposed rule 
making. 

d. The proposed text is not a changed 
version of proposed text the agency 
previously published in the course of 
rule-making proceedings but did not 
adopt. 



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(d) Text After Subject-Matter Notice. — When 
an agency publishes notice of the subject matter of 
proposed rule making in the North Carolina 
Register, it must subsequently publish in the North 
Carolina Register the text of the rule it proposes to 
adopt as a result of the public hearing and of any 
comments received on the subject matter. An 
agency may not publish the proposed text of a rule 
for which it published a subject-matter notice 
before the public hearing on the subject matter. 

(e) Comments. -- An agency must accept com- 
ments on the text of a proposed rule published in 
the North Carolina Register for at least 30 days 
after the text is published or until the date of any 
public hearing held on the proposed rule, whichev- 
er is longer. An agency must accept comments on 
a statement of the subject matter of proposed rule 
making until the public hearing on the subject 
matter. An agency must consider fully all written 
and oral comments received. 

(f) Adoption. -- An agency may not adopt a rule 
until the time for commenting on the proposed text 
of the rule has elapsed and may not adopt a rule if 
more than 12 months have elapsed since the end of 
the time for commenting on the proposed text of 
the rule. An agency may not adopt a rule that 
differs substantially from the text of a proposed 
rule published in the North Carolina Register 
unless the agency publishes the text of the pro- 
posed different rule in the North Carolina Register 
and accepts comments on the proposed different 
rule for the time set in subsection (e). 

An adopted rule differs substantially from a 
proposed rule if it does one or more of the follow- 
ing: 

(1) Affects the interests of persons who, 
based on the notice published in the 
North Carolina Register or the pro- 
posed text of the rule, could not reason- 
ably have determined that the rule 
would affect their interests. 

(2) Addresses a subject matter or an issue 
that is not addressed in the proposed 
text of the rule. 

(3) Produces an effect that could not rea- 
sonably have been expected based on 
the proposed text of the rule. 

When an agency adopts a rule, it may not take 
subsequent action on the rule without following the 
procedures in this Part. 

(g) Explanation. — An agency must issue a 
concise written statement explaining why the 
agency adopted a rule if, within 30 days after the 
agency adopts the rule, a person asks the agency to 
do so. The explanation must state the principal 



reasons for and against adopting the rule and must 
discuss why the agency rejected any arguments 
made or considerations urged against the adoption 
of the rule. 

(h) Record. — An agency must keep a record of 
a rule-making proceeding. The record must 
include all written comments received, a transcript 
or recording of any public hearing held on the 
rule, and any written explanation made by the 
agency for adopting the rule. 
§ 150B-21.3. Effective date of rules. 

(a) Temporary Rule. -- A temporary rule be- 
comes effective on the date the Codifier of Rules 
enters the rule in the North Carolina Administra- 
tive Code. 

(b) Permanent Rule. — A permanent rule ap- 
proved by the Commission becomes effective five 
business days after the Commission delivers the 
rule to the Codifier of Rules, unless the agency 
adopting the rule specifies a later effective date. 
If the agency specifies a later effective date, the 
rule becomes effective on that date. 

A permanent rule that is not approved by the 
Commission becomes effective five business days 
after the agency adopting the rule delivers the rule 
to the Codifier of Rules, unless the agency adopt- 
ing the rule specifies a later effective date. If the 
agency specifies a later effective date, the rule 
becomes effective on that date. 

(c) OSHA Standard. -- A permanent rule con- 
cerning an occupational safety and health standard 
that is adopted by the Occupational Safety and 
Health Division of the Department of Labor and is 
identical to a federal regulation promulgated by the 
Secretary of the United States Department of 
Labor becomes effective on the date the Division 
delivers the rule to the Codifier of Rules, unless 
the Division specifies a later effective date. If the 
Division specifies a later effective date, the rule 
becomes effective on that date. 

§ 150B-21.4. Fiscal notes on rules. 

(a) State Funds. -- Before an agency publishes in 
the North Carolina Register the proposed text of a 
permanent rule change that would require the 
expenditure or distribution of funds subject to the 
Executive Budget Act, Article 1 of Chapter 143, it 
must submit the text of the proposed rule change 
and a fiscal note on the proposed rule change to 
the Director of the Budget and obtain certification 
from the Director that the funds that would be 
required by the proposed rule change are available. 
The fiscal note must state the amount of funds that 
would be expended or distributed as a result of the 
proposed rule change and explain how the amount 
was computed. The Director of the Budget must 



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GENERAL STATUTES OF NORTH CAROLINA 



certify a proposed rule change if funds are avail- 
able to cover the expenditure or distribution 
required by the proposed rule change. 

(b) Local Funds. — Before an agency publishes 
in the North Carolina Register the proposed text of 
a permanent rule change that would affect the 
expenditures or revenues of a unit of local govern- 
ment, it must submit the text of the proposed rule 
change and a fiscal note on the proposed rule 
change to the Fiscal Research Division of the 
General Assembly, the Office of State Budget and 
Management, the North Carolina Association of 
County Commissioners, and the North Carolina 
League of Municipalities. The fiscal note must 
state the amount by which the proposed rule 
change would increase or decrease expenditures or 
revenues of a unit of local government and must 
explain how the amount was computed. 

(c) Errors. -- An erroneous fiscal note prepared 
in good faith does not affect the validity of a rule. 
§ 150B-21.5. Circumstances when notice and 
rule-making hearing not required. 

(a) Amendment. -- An agency is not required to 
publish a notice of rule making in the North 
Carolina Register or hold a public hearing when it 
proposes to amend a rule, without changing the 
substance of the rule, to do one of the following: 

( 1 ) Reletter or renumber the rule or 
subparts of the rule. 

(2) Substitute one name for another when 
an organization or position is renamed. 

(3) Correct a citation in the rule to another 
rule or law when the citation has be- 
come inaccurate since the rule was 
adopted because of the repeal or renum- 
bering of the cited rule or law. 

(4) Change information that is readily 
available to the public, such as an 
address or a telephone number. 

(5) Correct a typographical error made in 
entering the rule in the North Carolina 
Administrative Code. 

(6) Change a rule in response to a request 
or an objection by the Commission. 

(b) Repeal. -- An agency is not required to 
publish a notice of rule making in the North 
Carolina Register or hold a public hearing when it 
proposes to repeal a rule as a result of any of the 
following: 

( 1 ) The law under which the rule was 
adopted is repealed. 

(2) The law under which the rule was 
adopted or the rule itself is declared 
unconstitutional. 

(3) The rule is declared to be in excess of 



the agency's statutory authority. 

(c) OSHA Standard. - The Occupational Safety 
and Health Division of the Department of Labor is 
not required to publish a notice of rule making in 
the North Carolina Register or hold a public 
hearing when it proposes to adopt a rule that 
concerns an occupational safety and health stan- 
dard and is identical to a federal regulation pro- 
mulgated by the Secretary of the United States 
Department of Labor. The Occupational Safety 
and Health Division is not required to submit to 
the Commission for review a rule for which notice 
and hearing is not required under this subsection. 
§ 150B-21.6. Incorporating material in a rule 
by reference. 

An agency may incorporate the following materi- 
al by reference in a rule without repeating the text 
of the referenced material: 

( 1 ) Another rule or part of a rule adopted by 
the agency. 

(2) All or part of a code, standard, or regula- 
tion adopted by another agency, the 
federal government, or a generally recog- 
nized organization or association. 

(3) Material adopted to meet a requirement 
of the federal government. 

In incorporating material by reference, the 
agency must designate in the rule whether or not 
the incorporation includes subsequent amendments 
and editions of the referenced material. The 
agency can change this designation only by a 
subsequent rule-making proceeding. The agency 
must have copies of the incorporated material 
available for inspection and must specify in the 
rule both where copies of the material can be 
obtained and the cost on the date the rule is adopt- 
ed of a copy of the material. 

A statement in a rule that a rule incorporates 
material by reference in accordance with former 
G.S. I50B-14(b) is a statement that the rule does 
not include subsequent amendments and editions of 
the referenced material. A statement in a rule that 
a rule incorporates material by reference in accor- 
dance with former G.S. 150B- 14(c) is a statement 
that the rule includes subsequent amendments and 
editions of the referenced material. 
§ 150B-21.7. Effect of transfer of duties or 
termination of agency on rules. 

When a law that authorizes an agency to adopt a 
rule is repealed and another law gives the same or 
another agency substantially the same authority to 
adopt a rule, the rule remains in effect until the 
agency amends or repeals the rule. When a law 
that authorizes an agency to adopt a rule is re- 
pealed and another law does not give the same or 



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GENERAL STATUTES OF NORTH CAROLINA 



another agency substantially the same authority to 
adopt a rule, a rule adopted under the repealed law 
is repealed as of the date the law is repealed. 

When an executive order abolishes part or all of 
an agency and transfers a function of that agency 
to another agency, a rule concerning the trans- 
ferred function remains in effect until the agency 
to which the function is transferred amends or 
repeals the rule. When an executive order abolish- 
es part or all of an agency and does not transfer a 
function of that agency to another agency, a rule 
concerning a function abolished by the executive 
order is repealed as of the effective date of the 
executive order. 

The Director of Fiscal Research of the General 
Assembly must notify the Codifier of Rules when 
a rule is repealed under this section. When noti- 
fied of a rule repealed under this section, the 
Codifier of Rules must enter the repeal of the rule 
in the North Carolina Administrative Code. 

Part 3. Review by Commission. 
§ 150B-21.8. Review of rule by Commission. 
(a) Temporary Rule. — The Commission does 
not review a temporary rule. 

(b) Permanent Rule. -- An agency must submit 
a permanent rule adopted by it to the Commission 
before the rule can be included in the North 
Carolina Administrative Code. The Commission 
reviews a permanent rule in accordance with the 
standards in G.S. 150B-21.9 and follows the 
procedure in this Part in its review of a permanent 
rule. 

(c) Scope. -- When the Commission reviews an 
amendment to a rule, it may review the entire rule 
that is being amended. The procedure in G.S. 
150B-21.12 applies when the Commission objects 
to a part of a rule that is within its scope of review 
but is not changed by a rule amendment. 

§ 150B-21.9. Standards and timetable for 
review by Commission. 

(a) Standards. — The Commission must deter- 
mine whether a rule meets all of the following 
criteria: 

( 1 ) It is within the authority delegated to 
the agency by the General Assembly. 

(2) It is clear and unambiguous. 

(3) It is reasonably necessary to fulfill a 
duty delegated to the agency by the 
General Assembly. 

The Commission may determine if a rule submit- 
ted to it was adopted in accordance with Part 2 of 
this Article. The Commission must notify the 
agency that adopted the rule if it determines that a 
rule was not adopted in accordance with Part 2 of 
this Article and must return the rule to the agency. 



Entry of a rule in the North Carolina Administra- 
tive Code after review by the Commission is 
conclusive evidence that the rule was adopted in 
accordance with Part 2 of this Article. 

(b) Timetable. -- The Commission must review 
a rule submitted to it on or before the twentieth of 
a month by the last day of the next month. The 
Commission must review a rule submitted to it 
after the twentieth of a month by the last day of 
the second subsequent month. 
§ 150B-21.10. Commission action on perma- 
nent rule. 

At the first meeting at which a permanent rule is 
before the Commission for review, the Commis- 
sion must take one of the following actions: 

(1) Approve the rule, if the Commission 
determines that the rule meets the stan- 
dards for review. 

(2) Object to the rule, if the Commission 
determines that the rule does not meet the 
standards for review. 

(3) Extend the period for reviewing the rule, 
if the Commission determines it needs 
additional information on the rule to be 
able to decide whether the rule meets the 
standards for review. 

In reviewing a new rule or an amendment to an 
existing rule, the Commission may request an 
agency to make technical changes to the rule and 
may condition its approval of the rule on the 
agency's making the requested technical changes. 
§ 150B-21.il. Procedure when Commission 
approves permanent rule. 

When the Commission approves a permanent 
rule, it must notify the agency that adopted the 
rule of the Commission's approval and must 
deliver the approved rule to the Codifier of Rules. 
The Commission must deliver an approved rule by 
the end of the month in which the Commission 
approved the rule, unless the agency asks the 
Commission to delay the delivery of the rule. 
§ 150B-21.12. Procedure when Commission 
objects to a permanent rule. 

(a) Action. -- When the Commission objects to 
a permanent rule, it must send the agency that 
adopted the rule a written statement of the objec- 
tion and the reason for the objection. The agency 
that adopted the rule must take one of the follow- 
ing actions: 

( 1 ) Change the rule to satisfy the 
Commission's objection and submit the 
revised rule to the Commission. 

(2) Submit a written response to the Com- 
mission indicating that the agency has 
decided not to change the rule. 



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An agency that is not a board or commission 
must take one of these actions within 30 days after 
receiving the Commission's statement of objection. 
A board or commission must take one of these 
actions within 30 days after receiving the 
Commission's statement of objection or within 10 
days after the board or commission's next regular- 
ly scheduled meeting, whichever comes later. 

When an agency changes a rule in response to an 
objection by the Commission, the Commission 
must determine whether the change satisfies the 
Commission's objection. If it does, the Commis- 
sion must approve the rule. If it does not. the 
Commission must send the agency a written 
statement of the Commission's continued objection 
and the reason for the continued objection. 

A rule to which the Commission has objected 
remains under review by the Commission until the 
agency that adopted the rule decides not to satisfy 
the Commission's objection and makes a written 
request to the Commission to return the rule to the 
agency. When the Commission returns a rule to 
which it has objected, it may send to the President 
of the Senate and each member of the General 
Assembly a report of its objection to the rule. 

(b) Entry in Code. — When the Commission 
returns a rule to which it has objected to the 
agency that adopted the rule, the Commission must 
notify the Codifier of Rules of its action and of the 
basis of the Commission's objection. An agency 
whose rule is returned may file the rule with the 
Codifier of Rules. When the Codifier of Rules 
enters in the North Carolina Administrative Code 
a rule to which the Commission objected, the entry 
must reflect the Commission's objection and must 
state the standard on which the Commission based 
its objection. 

§ 150B-21 . 13. Procedure when Commission 
extends period for review of permanent rule. 

When the Commission extends the period for 
review of a permanent rule, it must notify the 
agency that adopted the rule of the extension and 
the reason for the extension. After the Commis- 
sion extends the period for review of a rule, it may 
call a public hearing on the rule. Within 70 days 
after extending the period for review of a rule, the 
Commission must decide whether to approve the 
rule, object to the rule, or call a public hearing on 
the rule. 
§ 150B-21 . 14. Public hearing on a rule. 

The Commission may call a public hearing on a 
rule when it extends the period for review of the 
rule. At the request of an agency, the Commission 
may call a public hearing on a rule that is not 
before it for review. Calling a public hearing on 



a rule not already before the Commission for 
review places the rule before the Commission for 
review. When the Commission decides to call a 
public hearing on a rule, it must publish notice of 
the public hearing in the North Carolina Register. 
After a public hearing on a rule, the Commission 
must approve the rule or object to the rule in 
accordance with the standards and procedures in 
this Part. The Commission must make its decision 
of whether to approve or object to the rule within 
70 days after the public hearing. 
§ 150B-21.15. Declaratory judgment action 
authorized when Commission objects to a per- 
manent rule. 

(a) Standing. -- A person aggrieved by a perma- 
nent rule entered in the North Carolina Adminis- 
trative Code with an objection by the Commission 
based on a lack of statutory authority may file an 
action for declaratory judgment in Wake County 
Superior Court pursuant to Article 26 of Chapter 
1 of the General Statutes. In the action, the court 
shall determine whether the agency exceeded its 
authority in adopting the rule. 

A declaratory judgment action under this section 
must be filed within 90 days after the rule that is 
the subject of the action is entered in the Code. 
Filing a petition for rule making or a request for a 
declaratory ruling with the agency that adopted the 
rule is not a prerequisite to filing an action under 
this section. A person who files an action for 
declaratory judgment under this section must serve 
a copy of the complaint on the agency that adopted 
the rule being contested, the Codifier of Rules, and 
the Commission. 

(b) Record. -- Within 10 days after a declarator)' 
judgment action is filed under this section, the 
agency that adopted the rule that is the subject of 
the action must send to the court the original or a 
certified copy of the record in the Commission's 
review of the rule. The record consists of the 
rule, the Commission's letter of objection to the 
rule, the agency's written response to the 
Commission's letter, and any other relevant docu- 
ments before the Commission when it decided to 
object to the rule. 

(c) Effect. -- A rule remains in effect during 
the pendency of an action for declaratory judgment 
under this section unless the court suspends the 
rule after finding that the agency that adopted the 
rule has no substantial likelihood of prevailing in 
the action. 

(d) Changes. -- While a rule is the subject of a 
declaratory judgment action under this section, the 
agency that adopted the rule may submit to the 
Commission changes in the rule to satisfy the 



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GENERAL STATUTES OF NORTH CAROLINA 



Commission's objection. If the Commission 
determines that changes submitted to it satisfy its 
objection, the Commission must accept the changes 
and file the revised rule with the Codifier of 
Rules. The Codifier must then enter the rule in 
the North Carolina Administrative Code. When 
the Commission determines that changes submitted 
to it satisfy its objection, the agency that submitted 
the changes must notify the court of the changes 
and of the Commission's action. 

Part 4. Publication of Code and Register. 
§ 150B-21.17. North Carolina Register. 

(a) Content. -- The Codifier of Rules must 
publish the North Carolina Register. The North 
Carolina Register must be published at least two 
times a month and must contain the following: 

( 1 ) Notices of proposed adoptions of rules. 

(2) Notices of receipt of a petition for 
municipal incorporation, as required by 
G.S. 120-165. 

(3) Executive orders of the Governor. 

(4) Final decision letters from the United 
States Attorney General concerning 
changes in laws that affect voting in a 
jurisdiction subject to § 5 of the Voting 
Rights Act of 1965, as required by 
G.S. 120-30. 9H. 

(5) Orders of the Tax Review Board issued 
under G.S. 105-241.2. 

(6) Other information the Codifier deter- 
mines helpful to the public. 

(b) Form. -- When an agency publishes notice in 
the North Carolina Register of the proposed text of 
a new rule, the Codifier of Rules must publish the 
complete text of the proposed new rule. In pub- 
lishing the text of a proposed new rule, the Codifi- 
er must indicate the rule is new by underlining the 
proposed text of the rule. 

When an agency publishes notice in the North 
Carolina Register of the proposed text of an 
amendment to an existing rule, the Codifier must 
publish the complete text of the rule that is being 
amended unless the Codifier determines that 
publication of the complete text of the rule being 
amended is not necessary to enable the reader to 
understand the proposed amendment. In publish- 
ing the text of a proposed amendment to a rule, 
the Codifier must indicate deleted text with over- 
strikes and added text with underlines. 

When an agency publishes notice in the North 
Carolina Register of the proposed repeal of an 
existing rule, the Codifier must publish the com- 
plete text of the rule the agency proposes to repeal 
unless the Codifier determines that publication of 
the complete text is impractical. In publishing the 



text of a rule the agency proposes to repeal, the 
Codifier must indicate the rule is to be repealed. 
§ 150B-21.18. North Carolina Administrative 
Code. 

The Codifier of Rules must compile all rules into 
a Code known as the North Carolina Administra- 
tive Code. The format and indexing of the Code 
must conform as nearly as practical to the format 
and indexing of the North Carolina General Stat- 
utes. The Codifier must publish printed copies of 
the Code and may publish the Code in other 
forms. The Codifier must keep the Code current 
by publishing the Code in a loose-leaf format and 
periodically providing new pages to be substituted 
for outdated pages, by publishing the Code in 
volumes and periodically publishing cumulative 
supplements, or by another means. The Codifier 
must keep superseded rules. 
§ 150B-21.19. Requirements for including 
rule in Code. 

To be acceptable for inclusion in the North 
Carolina Administrative Code, a rule must: 

( 1 ) Cite the law under which the rule is 
adopted. 

(2) Be signed by the head of the agency or 
the rule-making coordinator for the agen- 
cy that adopted the rule. 

(3) Be in the physical form specified by the 
Codifier of Rules. 

(4) Have been reviewed by the Commission, 
if the rule is a permanent rule. 

§ 150B-21.20. Codifier's authority to revise 
form of rules. 

(a) Authority. -- After consulting with the 
agency that adopted the rule, the Codifier of Rules 
may revise the form of a rule submitted for inclu- 
sion in the North Carolina Administrative Code 
within 10 business days after the rule is submitted 
to do one or more of the following: 

( 1 ) Rearrange the order of the rule in the 
Code or the order of the subsections, 
subdivisions, or other subparts of the 
rule. 

(2) Provide a catch line or heading for the 
rule or revise the catch line or heading 
of the rule. 

(3) Reletter or renumber the rule or the 
subparts of the rule in accordance with 
a uniform system. 

(4) Rearrange definitions and lists. 

(5) Make other changes in arrangement or 
in form that do not change the sub- 
stance of the rule and are necessary or 
desirable for a clear and orderly ar- 
rangement of the rule. 



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(b) Effect. — Revision of a rule by the Codifier 
of Rules under this section does not affect the 
effective date of the rule or require the agency to 
readopt or resubmit the rule. When the Codifier 
of Rules revises the form of a rule, the Codifier of 
Rules must send the agency that adopted the rule 
a copy of the revised rule. The revised rule is the 
official rule. 

§ 150B-21.21. Publication of rules of North 
Carolina State Bar and exempt agencies. 

(a) State Bar. -- The North Carolina State Bar 
must submit a rule adopted or approved by it and 
entered in the minutes of the North Carolina 
Supreme Court to the Codifier of Rules for inclu- 
sion in the North Carolina Administrative Code. 
The State Bar must submit a rule within 15 days 
after it is entered in the minutes of the Supreme 
Court. The Codifier of Rules must compile, make 
available for public inspection, and publish a rule 
included in the North Carolina Administrative 
Code under this subsection in the same manner as 
other rules in the Code. 

(b) Exempt Agencies. — Notwithstanding G.S. 
150B-1, the North Carolina Utilities Commission 
must submit to the Codifier of Rules those rules of 
the Utilities Commission that are published from 
time to time in the publication titled "North Caroli- 
na Utilities Laws and Regulations." The Utilities 
Commission must submit a rule required to be 
included in the Code within 15 days after it is 
adopted. The Codifier of Rules must publish the 
rules submitted by the Utilities Commission in the 
North Carolina Administrative Code in the same 
format as they are submitted. 

Notwithstanding G.S. 150B-1, an agency other 
than the Utilities Commission that is exempted 
from this Article by that statute must submit a 
temporary or permanent rule adopted by it to the 
Codifier of Rules for inclusion in the North Caroli- 
na Administrative Code. One of these exempt 
agencies must submit a rule to the Codifier of 
Rules within 15 days after it adopts the rule. The 
Codifier of Rules must compile, make available for 
public inspection, and publish a rule of one of 
these agencies in the North Carolina Administra- 
tive Code in the same manner as other rules in the 
Code. 
§ 150B-21. 22. Effect of inclusion in Code. 

Official or judicial notice can be taken of a rule 
in the North Carolina Administrative Code and 
shall be taken when appropriate. Codification of a 
rule in the North Carolina Administrative Code is 
prima facie evidence of compliance with this 
Article. 
§ 150B-21.23. Rule publication manual. 



The Codifier of Rules must publish a manual that 
sets out the form and method for publishing a 
notice of rule making in the North Carolina Regis- 
ter and for filing a rule in the North Carolina 
Administrative Code. 

§ 150B-21.24. Free copies of Register and 
Code. 

(a) Register. — The Codifier of Rules must 
distribute copies of the North Carolina Register as 
soon after publication as practical, without charge, 
to the following: 

(1) A person who receives a free copy of 
the North Carolina Administrative 
Code. 

(2) Upon request, one copy to each mem- 
ber of the General Assembly. 

(b) Code. — The Codifier of Rules must distrib- 
ute copies of the North Carolina Administrative 
Code as soon after publication as practical, without 
charge, to the following: 

( 1 ) One copy to the board of commission- 
ers of each county, to be placed at the 
county clerk of court's office or at 
another place selected by the board of 
commissioners. 

(2) One copy to the Commission. 

(3) One copy to the Clerk of the Supreme 
Court and to the Clerk of the Court of 
Appeals of North Carolina. 

(4) One copy to the Supreme Court Library 
and one copy to the library of the Court 
of Appeals. 

(5) One copy to the Administrative Office 
of the Courts. 

(6) One copy to the Governor. 

(7) Five copies to the Legislative Services 
Commission for the use of the General 
Assembly. 

(8) Upon request, one copy to each State 
official or department to whom or to 
which copies of the appellate division 
reports are furnished under G.S. 
7A-343.1. 

(9) Five copies to the Division of State 
Library of the Department of Cultural 
Resources pursuant to G.S. 125-11.7. 

§ 150B-21.25. Paid copies of Register and 
Code. 

A person who is not entitled to a free copy of the 
North Carolina Administrative Code or North 
Carolina Register may obtain a copy by paying a 
fee set by the Codifier of Rules. The Codifier 
must set separate fees for the North Carolina 
Register and the North Carolina Administrative 
Code in amounts that cover publication, copying. 



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and mailing costs. All monies received under this 
section must be credited to the General Fund. 
Article 3. 
Administrative Hearings. 
§ 150B-22. Settlement; contested case. 

It is the policy of this State that any dispute 
between an agency and another person that in- 
volves the person's rights, duties, or privileges, 
including licensing or the levy of a monetary 
penalty, should be settled through informal proce- 
dures. In trying to reach a settlement through 
informal procedures, the agency may not conduct 
a proceeding at which sworn testimony is taken 
and witnesses may be cross-examined. If the 
agency and the other person do not agree to a 
resolution of the dispute through informal proce- 
dures, either the agency or the person may com- 
mence an administrative proceeding to determine 
the person's rights, duties, or privileges, at which 
time the dispute becomes a "contested case." 
§ 150B-23. Commencement; assignment of 
administrative law judge; hearing required; 
notice: intervention. 

(a) A contested case shall be commenced by 
filing a petition with the Office of Administrative 
Hearings and, except as provided in Article 3A of 
this Chapter, shall be conducted by that Office. 
The party who files the petition shall serve a copy 
of the petition on all other parties and, if the 
dispute concerns a license, the person who holds 
the license. A party who files a petition shall file 
a certificate of service together with the petition. 
A petition shall be signed by a party or a represen- 
tative of the party and, if filed by a party other 
than an agency, shall state facts tending to estab- 
lish that the agency named as the respondent has 
deprived the petitioner of property, has ordered the 
petitioner to pay a fine or civil penalty, or has 
otherwise substantially prejudiced the petitioner's 
rights and that the agency: 

(1) Exceeded its authority or jurisdiction; 

(2) Acted erroneously; 

(3) Failed to use proper procedure; 

(4) Acted arbitrarily or capriciously; or 

(5) Failed to act as required by law or rule. 
The parties in a contested case shall be given an 

opportunity for a hearing without undue delay. 
Any person aggrieved may commence a contested 
case hereunder. 

A local government employee, applicant for 
employment, or former employee to whom Chap- 
ter 126 of the General Statutes applies may com- 
mence a contested case under this Article in the 
same manner as any other petitioner. The case 
shall be conducted in the Office of Administrative 



Hearings in the same manner as other contested 
cases under this Article, except that the decision of 
the State Personnel Commission shall be advisory 
only and not binding on the local appointing 
authority, unless (1) the employee, applicant, or 
former employee has been subjected to discrimina- 
tion prohibited by Article 6 of Chapter 126 of the 
General Statutes or (2) applicable federal stan- 
dards require a binding decision. In these two 
cases, the State Personnel Commission's decision 
shall be binding. 

(al) Repealed by Session Laws 1985 (Reg. 
Sess.. 1986), c. 1022, s. 1(9). 

(a2) An administrative law judge assigned to a 
contested case may require a party to the case to 
file a prehearing statement. A party's prehearing 
statement must be served on all other parties to the 
contested case. 

(b) The parties to a contested case shall be given 
a notice of hearing not less than 15 days before the 
hearing by the Office of Administrative Hearings. 
If prehearing statements have been filed in the 
case, the notice shall state the date, hour, and 
place of the hearing. If prehearing statements 
have not been filed in the case, the notice shall 
state the date. hour, place, and nature of the 
hearing, shall list the particular sections of the 
statutes and rules involved, and shall give a short 
and plain statement of the factual allegations. 

(c) Notice shall be given personally or by 
certified mail. If given by certified mail, it shall 
be deemed to have been given on the delivery date 
appearing on the return receipt. If giving of notice 
cannot be accomplished either personally or by 
certified mail, notice shall then be given in the 
manner provided in G.S. 1A-1, Rule 4(jl). 

(d) Any person may petition to become a party 
by filing a motion to intervene in the manner 
provided in G.S. 1A-1, Rule 24. In addition, any 
person interested in a contested case may intervene 
and participate in that proceeding to the extent 
deemed appropriate by the administrative law 
judge. 

(e) All hearings under this Chapter shall be open 
to the public. Hearings shall be conducted in an 
impartial manner. Hearings shall be conducted 
according to the procedures set out in this Article, 
except to the extent and in the particulars that 
specific hearing procedures and time standards are 
governed by another statute. 

(f) Unless another statute or a federal statute or 
regulation sets a time limitation for the filing of a 
petition in contested cases against a specified 
agency, the general limitation for the filing of a 
petition in a contested case is 60 days. The time 



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limitation, whether established by another statute, 
federal statute, or federal regulation, or this 
section, shall commence when notice is given of 
the agency decision to all persons aggrieved who 
are known to the agency by personal delivery or 
by the placing of the notice in an official deposito- 
ry of the United States Postal Service wrapped in 
a wrapper addressed to the person at the latest 
address given by the person to the agency. The 
notice shall be in writing, and shall set forth the 
agency action, and shall inform the persons of the 
right, the procedure, and the time limit to file a 
contested case petition. When no informal settle- 
ment request has been received by the agency 
prior to issuance of the notice, any subsequent 
informal settlement request shall not suspend the 
time limitation for the filing of a petition for a 
contested case hearing. 
§ 150B-24. Venue of hearing. 

(a) The hearing of a contested case shall be 
conducted: 

( 1 ) In the county in this State in which any 
person whose property or rights are the 
subject matter of the hearing maintains 
his residence; 

(2) In the county where the agency main- 
tains its principal office if the property 
or rights that are the subject matter of 
the hearing do not affect any person or 
if the subject matter of the hearing is 
the property or rights of residents of 
more than one county; or 

(3) In any county determined by the admin- 
istrative law judge in his discretion to 
promote the ends of justice or better 
serve the convenience of witnesses. 

(b) Any person whose property or rights are the 
subject matter of the hearing waives his objection 
to venue by proceeding in the hearing. 

§ 150B-25. Conduct of hearing: answer. 

(a) If a party fails to appear in a contested case 
after proper service of notice, and if no adjourn- 
ment or continuance is granted, the administrative 
law judge may proceed with the hearing in the 
absence of the party. 

(b) Repealed. 

(c) The parties shall be given an opportunity to 
present arguments on issues of law and policy and 
an opportunity to present evidence on issues of 
fact. 

(d) A party may cross-examine any witness, 
including the author of a document prepared by, 
on behalf of. or for use of the agency and offered 
in evidence. Any party may submit rebuttal evidence. 
§ 150B-26. Consolidation. 



When contested cases involving a common 
question of law or fact or multiple proceedings 
involving the same or related parties are pending, 
the Director of the Office of Administrative Hear- 
ings may order a joint hearing of any matters at 
issue in the cases, order the cases consolidated, or 
make other orders to reduce costs or delay in the 
proceedings. 
§ 150B-27. Subpoena. 

After the commencement of a contested case, 
subpoenas may be issued and served in accordance 
with G.S. 1A-1, Rule 45. In addition to the 
methods of service in G.S. 1A-1, Rule 45, a State 
law enforcement officer may serve a subpoena on 
behalf of an agency that is a party to the contested 
case by any method by which a sheriff may serve 
a subpoena under that Rule. Upon a motion, the 
administrative law judge may quash a subpoena if. 
upon a hearing, the administrative law judge finds 
that the evidence the production of which is re- 
quired does not relate to a matter in issue, the 
subpoena does not describe with sufficient particu- 
larity the evidence the production of which is 
required, or for any other reason sufficient in law 
the subpoena may be quashed. Witness fees shall 
be paid by the party requesting the subpoena to 
subpoenaed witnesses in accordance with G.S. 
7A-314. However, State officials or employees 
who are subpoenaed shall not be entitled to witness 
fees, but they shall receive their normal salary and 
they shall not be required to take any annual leave 
for the witness days. Travel expenses of State 
officials or employees who are subpoenaed shall be 
reimbursed as provided in G.S. 138-6. 
§ 150B-28. Depositions and discovery. 

(a) A deposition may be used in lieu of other 
evidence when taken in compliance with the Rules 
of Civil Procedure. G.S. 1A-1. Parties in contest- 
ed cases may engage in discovery pursuant to the 
provisions of the Rules of Civil Procedure, G.S. 
1A-1. 

(b) On a request for identifiable agency records, 
with respect to material facts involved in a contest- 
ed case, except records related solely to the inter- 
nal procedures of the agency or which are exempt 
from disclosure by law, an agency shall promptly 
make the records available to a party. 

§ 150B-29. Rules of evidence. 

(a) In all contested cases, irrelevant, immaterial 
and unduly repetitious evidence shall be excluded. 
Except as otherwise provided, the rules of evi- 
dence as applied in the trial division of the General 
Court of Justice shall be followed; but, when 
evidence is not reasonably available under the 
rules to show relevant facts, then the most reliable 



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and substantial evidence available shall be admit- 
ted. On the judge's own motion, an administrative 
law judge may exclude evidence that is inadmissi- 
ble under this section. It shall not be necessary 
for a party or his attorney to object at the hearing 
to evidence in order to preserve the right to object 
to its consideration by the administrative law judge 
in making a recommended decision, by the agency 
in making a final decision, or by the court on 
judicial review. 

(b) Evidence in a contested case, including 
records and documents, shall be offered and made 
a part of the record. Factual information or 
evidence not made a part of the record shall not be 
considered in the determination of the case, except 
as permitted under G.S. 150B-30. Documentary 
evidence may be received in the form of a copy or 
excerpt or may be incorporated by reference, if the 
materials so incorporated are available for exami- 
nation by the parties. Upon timely request, a 
party shall be given an opportunity to compare the 
copy with the original if available. 
§ 150B-30. Official notice. 

Official notice may be taken of all facts of which 
judicial notice may be taken and of other facts 
within the specialized knowledge of the agency. 
The noticed fact and its source shall be stated and 
made known to affected parties at the earliest 
practicable time, and any party shall on timely 
request be afforded an opportunity to dispute the 
noticed fact through submission of evidence and 
argument. 
§ I50B-31. Stipulations. 

(a) The parties in a contested case may, by a 
stipulation in writing filed with the administrative 
law judge, agree upon any fact involved in the 
controversy, which stipulation shall be used as 
evidence at the hearing and be binding on the 
parties thereto. Parties should agree upon facts 
when practicable. 

(b) Except as otherwise provided by law, dispo- 
sition may be made of a contested case by stipula- 
tion, agreed settlement, consent order, waiver, 
default, or other method agreed upon by the 
parties. 

§ 150B-32. Designation of administrative law 
judge. 

(a) The Director of the Office of Administrative 
Hearings shall assign himself or another adminis- 
trative law judge to preside over a contested case. 

(al) Repealed by Session Laws 1985 (Reg. 
Sess., 1986), c. 1022. s. 1 ( 15), effective July 15, 
1986. 

(b) On the filing in good faith by a party of a 
timely and sufficient affidavit of personal bias or 



disqualification of an administrative law judge, the 
administrative law judge shall determine the matter 
as a part of the record in the case, and this deter- 
mination shall be subject to judicial review at the 
conclusion of the proceeding. 

(c) When an administrative law judge is disqual- 
ified or it is impracticable for him to continue the 
hearing, the Director shall assign another adminis- 
trative law judge to continue with the case unless 
it is shown that substantial prejudice to any party 
will result, in which event a new hearing shall be 
held or the case dismissed without prejudice. 
§ 150B-33. Powers of administrative law 

judge. 

(a) An administrative law judge shall stay any 
contested case under this Article on motion of an 
agency which is a party to the contested case, if 
the agency shows by supporting affidavits that it is 
engaged in other litigation or administrative pro- 
ceedings, by whatever name called, with or before 
a federal agency, and this other litigation or 
administrative proceedings will determine the 
position, in whole or in part, of the agency in the 
contested case. At the conclusion of the other 
litigation or administrative proceedings, the con- 
tested case shall proceed and be determined as 
expeditiously as possible. 

(b) An administrative law judge may: 

(1) Administer oaths and affirmations; 

(2) Sign, issue, and rule on subpoenas in 
accordance with G.S. 150B-27 and 
G.S. IA-1, Rule 45; 

(3) Provide for the taking of testimony by 
deposition and rule on all objections to 
discovery in accordance with G.S. 
IA-1, the Rules of Civil Procedure; 

(3a) Rule on all prehearing motions that are 
authorized by G.S. IA-1, the Rules of 
Civil Procedure; 

(4) Regulate the course of the hearings, 
including discovery, set the time and 
place for continued hearings, and fix 
the time for filing of briefs and other 
documents; 

(5) Direct the parties to appear and confer 
to consider simplification of the issues 
by consent oT the parties; 

(6) Stay the contested action by the agency 
pending the outcome of the case, upon 
such terms as he deems proper, and 
subject to the provisions of G.S. IA-1. 
Rule 65; 

(7) Determine whether the hearing shall be 
recorded by a stenographer or by an 
electronic device; and 



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(8) Enter an order returnable in the General 
Court of Justice. Superior Court Divi- 
sion, to show cause why the person 
should not be held in contempt. The 
Court shall have the power to impose 
punishment as for contempt for any act 
which would constitute direct or indi- 
rect contempt if the act occurred in an 
action pending in Superior Court. 

(9) Determine that a rule as applied in a 
particular case is void because ( I ) it is 
not within the statutory authority of the 
agency. (2) is not clear and unambigu- 
ous to persons it is intended to direct, 
guide, or assist, or (3) is not reasonably 
necessary to enable the agency to fulfill 
a dutv delegated to it by the General 
Assembly. 

(10) Impose the sanctions provided for in 
G.S. 1 A-l or Chapter 3 of Title 26 of 
the North Carolina Administrative Code 
for noncompliance with applicable 
procedural rules. 

§ 150B-34. Recommended decision or order 
of administrative law judge. 

(a) Except as provided in G.S. 150B-36(c), in 
each contested case the administrative law judge 
shall make a recommended decision or order that 
contains findings of fact and conclusions of law. 

(b) Repealed. 

§ 150B-35. No ex parte communication; 

exceptions. 

Unless required for disposition of an ex parte 
matter authorized by law. neither the administra- 
tive law judge assigned to a contested case nor a 
member or employee of the agency making a final 
decision in the case may communicate, directly or 
indirectly, in connection with any issue of fact, or 
question of law, with any person or party or his 
representative, except on notice and opportunity 
for all parties to participate. 
§ 150B-36. Final decision. 

(a) Before the agency makes a final decision, it 
shall give each party an opportunity to file excep- 
tions to the decision recommended by the adminis- 
trative law judge, and to present written arguments 
to those in the agency who will make the final 
decision or order. If a party files in good faith a 
timely and sufficient affidavit of personal bias or 
other reason for disqualification of a member of 
the agency making the final decision, the agency 
shall determine the matter as a part of the record 
in the case, and the determination is subject to 
judicial review at the conclusion of the case. 

(b) A final decision or order in a contested case 



shall be made by the agency in writing after 
review of the official record as defined in G.S. 
150B-37(a) and shall include findings of fact and 
conclusions of law. If the agency does not adopt 
the administrative law judge's recommended 
decision as its final decision, the agency shall state 
in its decision or order the specific reasons why it 
did not adopt the administrative law judge's rec- 
ommended decision. The agency may consider 
only the official record prepared pursuant to G.S. 
150B-37 in making a final decision or order, and 
the final decision or order shall be supported by 
substantial evidence admissible under G.S. 
150B-29(a). 150B-30. or 150B-31. A copy of the 
decision or order shall be served upon each party 
personally or by certified mail addressed to the 
party at the latest address given by the party to the 
agency, and a copy shall be furnished to his 
attorney of record and the Office of Administrative 
Hearings. 

(c) The following decisions made by administra- 
tive law judges in contested cases are final deci- 
sions: 

( 1 ) A determination that the Office of 
Administrative Hearings lacks jurisdic- 
tion. 

(2) An order entered pursuant to the au- 
thority in G.S. 7A-759(e). 

(3) An order entered pursuant to a written 
prehearing motion that either dismisses 
the contested case for failure of the 
petitioner to prosecute or grants the 
relief requested when a party does not 
comply with procedural requirements. 

(4) An order entered pursuant to a 
prehearing motion to dismiss the con- 
tested case in accordance with G.S. 
I A-l, Rule 12(b) when the order dis- 
poses of all issues in the contested case. 

§ 150B-37. Official record. 

(a) In a contested case, the Office of Adminis- 
trative Hearings shall prepare an official record of 
the case that includes: 

(1) Notices, pleadings, motions, and inter- 
mediate rulings; 

(2) Questions and offers of proof, objec- 
tions, and rulings thereon: 

(3) Evidence presented: 

(4) Matters officially noticed, except mat- 
ters so obvious that a statement of them 
would serve no useful purpose: and 

(5) Repealed by Session Laws 1987. c. 
878. s. 25. effective August 14. 1987. 

(6) The administrative law judge's recom- 
mended decision or order. 



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GENERAL STATUTES OF NORTH CAROLINA 



(b) Proceedings at which oral evidence is 
presented shall be recorded, but need not be 
transcribed unless requested by a party. Each 
party shall bear the cost of the transcript or part 
thereof or copy of said transcript or part thereof 
which said party requests, and said transcript or 
part thereof shall be added to the official record as 
an exhibit. 

(c) The Office of Administrative Hearings shall 
forward a copy of the official record to the agency 
making the final decision and shall forward a copy 
of the recommended decision to each party. 
Article 3A. 
Other Administrative Hearings. 
§ 150B-38. Scope; hearing required; notice; 
venue. 

(a) The provisions of this Article shall apply to 
the following agencies: 

(1) Occupational licensing agencies; 

(2) The State Banking Commission, the 
Commissioner of Banks, the Savings 
Institutions Division of the Department 
of Economic and Community Develop 
ment. Commerce, and the Credit Union 
Division of the Department of Econom 
ic and Community Dev e lopment; Com- 
merce; and 

(3) The Department of Insurance and the 
Commissioner of Insurance. 

(b) Prior to any agency action in a contested 
case, the agency shall give the parties in the case 
an opportunity for a hearing without undue delay 
and notice not less than 15 days before the hear- 
ing. Notice to the parties shall include: 

( 1 ) A statement of the date, hour, place, 
and nature of the hearing; 

(2) A reference to the particular sections of 
the statutes and rules involved; and 

(3) A short and plain statement of the facts 
alleged. 

(c) Notice shall be given personally or by 
certified mail. If given by certified mail, notice 
shall be deemed to have been given on the delivery 
date appearing on the return receipt. If notice 
cannot be given personally or by certified mail, 
then notice shall be given in the manner provided 
in G.S. 1A-1, Rule 4(J1). 

(d) A party who has been served with a notice 
of hearing may file a written response with the 
agency. If a written response is filed, a copy of 
the response must be mailed to all other parties not 
less than 10 days before the date set for the hear- 
ing. 

(e) All hearings conducted under this Article 
shall be open to the public. A hearing conducted 



by the agency shall be held in the county where 
the agency maintains its principal office. A 
hearing conducted for the agency by an administra- 
tive law judge requested under G.S. 150B-40 shall 
be held in a county in this State where any person 
whose property or rights are the subject matter of 
the hearing resides. If a different venue would 
promote the ends of justice or better serve the 
convenience of witnesses, the agency or the admin- 
istrative law judge may designate another county. 
A person whose property or rights are the subject 
matter of the hearing waives his objection to venue 
if he proceeds in the hearing. 

(f) Any person may petition to become a party 
by filing with the agency or hearing officer a 
motion to intervene in the manner provided by 
G.S. 1A-1, Rule 24. In addition, any person 
interested in a contested case under this Article 
may intervene and participate to the extent deemed 
appropriate by the agency hearing officer. 

(g) When contested cases involving a common 
question of law or fact or multiple proceedings 
involving the same or related parties are pending 
before an agency, the agency may order a joint 
hearing of any matters at issue in the cases, order 
the cases consolidated, or make other orders to 
reduce costs or delay in the proceedings. 

(h) Every agency shall adopt rules governing the 
conduct of hearings that are consistent with the 
provisions of this Article. 

§ 150B-39. Depositions; discovery; subpoe- 
nas. 

(a) A deposition may be used in lieu of other 
evidence when taken in compliance with the Rules 
of Civil Procedure, G.S. 1A-1. Parties in a 
contested case may engage in discovery pursuant 
to the provisions of the Rules of Civil Procedure, 
G.S. 1A-1. 

(b) Upon a request for an identifiable agency 
record involving a material fact in a contested 
case, the agency shall promptly provide the record 
to a party, unless the record relates solely to the 
agency"s internal procedures or is exempt from 
disclosure by law. 

(c) In preparation for, or in the conduct of, a 
contested case subpoenas may be issued and served 
in accordance with G.S. 1A-I. Rule 45. Upon a 
motion, the agency may quash a subpoena if, upon 
a hearing, the agency finds that the evidence, the 
production of which is required, does not relate to 
a matter in issue, the subpoena does not describe 
with sufficient particularity the evidence the 
production of which is required, or for any other 
reason sufficient in law the subpoena may be 
quashed. Witness fees shall be paid by the party 



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2076 



GENERAL STATUTES OF NORTH CAROLINA 



requesting the subpoena to subpoenaed witnesses 
in accordance with G.S. 7A-314. However, State 
officials or employees who are subpoenaed shall 
not be entitled to any witness fees, but they shall 
receive their normal salary and they shall not be 
required to take any annual leave for the witness 
days. Travel expenses of State officials or em- 
ployees who are subpoenaed shall be reimbursed 
as provided in G.S. 138-6. 

§ 150B-40. Conduct of hearing: presiding 
officer: ex parte communication. 

(a) Hearings shall be conducted in a fair and 
impartial manner. At the hearing, the agency and 
the parties shall be given an opportunity to present 
evidence on issues of fact, examine and 
cross-examine witnesses, including the author of a 
document prepared by. on behalf of or for the use 
of the agency and offered into evidence, submit 
rebuttal evidence, and present arguments on issues 
of law or policy. 

If a party fails to appear in a contested case after 
he has been given proper notice, the agency may 
continue the hearing or proceed with the hearing 
and make its decision in the absence of the party. 

(b) Except as provided under subsection (e) of 
this section, hearings under this Article shall be 
conducted by a majority of the agency. An agency 
shall designate one or more of its members to 
preside at the hearing. If a party files in good 
faith a timely and sufficient affidavit of the person- 
al bias or other reason for disqualification of any 
member of the agency, the agency shall determine 
the matter as a part of the record in the case, and 
its determination shall be subject to judicial review 
at the conclusion of the proceeding. If a presiding 
officer is disqualified or it is impracticable for him 
to continue the hearing, another presiding officer 
shall be assigned to continue with the case, except 
that if assignment of a new presiding officer will 
cause substantial prejudice to any party, a new 
hearing shall be held or the case dismissed without 
prejudice. 

(c) The presiding officer may: 

(1) Administer oaths and affirmations; 

(2) Sign and issue subpoenas in the name 
of the agency, requiring attendance and 
giving of testimony by witnesses and 
the production of books, papers, and 
other documentary evidence; 

(3) Provide for the taking of testimony by 
deposition: 

i4i Regulate the course of the hearings, set 
the time and place for continued hear- 
ings, and fix the time for filing of 
briefs and other documents; 



(5) Direct the parties to appear and confer 
to consider simplification of the issues 
by consent of the parties; and 

(6) Apply to any judge of the superior 
court resident in the district or presid- 
ing at a term of court in the county 
where a hearing is pending for an order 
to show cause why any person should 
not be held in contempt of the agency 
and its processes, and the court shall 
have the power to impose punishment 
as for contempt for acts which would 
constitute direct or indirect contempt if 
the acts occurred in an action pending 
in superior court. 

(d) Unless required for disposition of an ex 
parte matter authorized by law, a member of an 
agency assigned to make a decision or to make 
findings of fact and conclusions of law in a con- 
tested case under this Article shall not communi- 
cate, directly or indirectly, in connection with any 
issue of fact or question of law, with any person or 
party or his representative, except on notice and 
opportunity for all parties to participate. This 
prohibition begins at the time of the notice of 
hearing. An agency member may communicate 
with other members of the agency and may have 
the aid and advice of the agency staff other than 
the staff which has been or is engaged in investi- 
gating or prosecuting functions in connection with 
the case under consideration or a factually-related 
case. This section does not apply to an agency 
employee or party representative with professional 
training in accounting, actuarial science, econom- 
ics or financial analysis insofar as the case in- 
volves financial practices or conditions. 

(e) When a majority of an agency is unable or 
elects not to hear a contested case, the agency shall 
apply to the Director of the Office of Administra- 
tive Hearings for the designation of an administra- 
tive law judge to preside at the hearing of a con- 
tested case under this Article. Upon receipt of the 
application, the Director shall, without undue 
delay, assign an administrative law judge to hear 
the case. 

The provisions of this Article, rather than the 
provisions of Article 3. shall govern a contested 
case in which the agency requests an administra- 
tive law judge from the Office of Administrative 
Hearings. 

The administrative law judge assigned to hear a 
contested case under this Article shall sit in place 
of the agency and shall have the authority of the 
presiding officer in a contested case under this 
Article. The administrative law judge shall make 



2077 



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January 4, 1993 



GENERAL STATUTES OF NORTH CAROLINA 



a proposal for decision, which shall contain pro- 
posed findings of fact and proposed conclusions of 
law. 

An administrative law judge shall stay any 
contested case under this Article on motion of an 
agency which is a party to the contested case, if 
the agency shows by supporting affidavits that it is 
engaged in other litigation or administrative pro- 
ceedings, by whatever name called, with or before 
a federal agency, and this other litigation or 
administrative proceedings will determine the 
position, in whole or in part, of the agency in the 
contested case. At the conclusion of the other 
litigation or administrative proceedings, the con- 
tested case shall proceed and be determined as 
expeditiously as possible. 

The agency may make its final decision only 
after the administrative law judge's proposal for 
decision is served on the parties, and an opportuni- 
ty is given to each party to file exceptions and 
proposed findings of fact and to present oral and 
written arguments to the agency. 
§ 150B-41. Evidence; stipulations; official 
notice. 

(a) In all contested cases, irrelevant, immaterial, 
and unduly repetitious evidence shall be excluded. 
Except as otherwise provided, the rules of evi- 
dence as applied in the trial division of the General 
Court of Justice shall be followed; but, when 
evidence is not reasonably available under such 
rules to show relevant facts, they may be shown 
by the most reliable and substantial evidence 
available. It shall not be necessary for a party or 
his attorney to object to evidence at the hearing in 
order to preserve the right to object to its consider- 
ation by the agency in reaching its decision, or by 
the court of judicial review. 

(b) Evidence in a contested case, including 
records and documents shall be offered and made 
a part of the record. Other factual information or 
evidence shall not be considered in determination 
of the case, except as permitted under G.S. 
150B-30. Documentary evidence may be received 
in the form of a copy or exceipt or may be incor- 
porated by reference, if the materials so incorpo- 
rated are available for examination by the parties. 
Upon timely request, a party shall be given an 
opportunity to compare the copy with the original 
if available. 

(c) The parties in a contested case under this 
Article by a stipulation in writing filed with the 
agency may agree upon any fact involved in the 
controversy, which stipulation shall be used as 
evidence at the hearing and be binding on the 
parties thereto. Parties should agree upon facts 



when practicable. Except as otherwise provided 
by law, disposition may be made of a contested 
case by stipulation, agreed settlement, consent 
order, waiver, default, or other method agreed 
upon by the parties. 

(d) Official notice may be taken of all facts of 
which judicial notice may be taken and of other 
facts within the specialized knowledge of the 
agency. The noticed fact and its source shall be 
stated and made known to affected parties at the 
earliest practicable time, and any party shall on 
timely request be afforded an opportunity to 
dispute the noticed fact through submission of 
evidence and argument. An agency may use its 
experience, technical competence, and specialized 
knowledge in the evaluation of evidence presented 
to it. 

§ 150B-42. Final agency decision; official 
record. 

(a) After compliance with the provisions of G.S. 
150B-40(e), if applicable, and review of the 
official record, as defined in subsection (b) of this 
section, an agency shall make a written final 
decision or order in a contested case. The deci- 
sion or order shall include findings of fact and 
conclusions of law. Findings of fact shall be based 
exclusively on the evidence and on matters offi- 
cially noticed. Findings of fact, if set forth in 
statutory language, shall be accompanied by a 
concise and explicit statement of the underlying 
facts supporting them. A decision or order shall 
not be made except upon consideration of the 
record as a whole or such portion thereof as may 
be cited by any party to the proceeding and shall 
be supported by substantial evidence admissible 
under G.S. 150B-41. A copy of the decision or 
order shall be served upon each party personally 
or by certified mail addressed to the party at the 
latest address given by the party to the agency and 
a copy shall be furnished to his attorney of record. 

(b) An agency shall prepare an official record of 
a hearing that shall include: 

( 1 ) Notices, pleadings, motions, and inter- 
mediate rulings; 

(2) Questions and offers of proof, objec- 
tions, and rulings thereon; 

(3) Evidence presented; 

(4) Matters officially noticed, except mat- 
ters so obvious that a statement of them 
would serve no useful purpose; 

(5) Proposed findings and exceptions; and 

(6) Any decision, opinion, order, or report 
by the officer presiding at the hearing 
and by the agency. 

(c) Proceedings at which oral evidence is pre- 



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2078 



GENERAL STATUTES OF NORTH CAROLINA 



sented shall be recorded, but need not be tran- 
scribed unless requested by a party. Each party 
shall bear the cost of the transcript or part thereof 
or copy of said transcript or part thereof which 
said party requests. 

Article 4. 
Judicial Review. 
§ 150B-43. Right to judicial review. 

Any person who is aggrieved by the final deci- 
sion in a contested case, and who has exhausted all 
administrative remedies made available to him by 
statute or agency rule, is entitled to judicial review 
of the decision under this Article, unless adequate 
procedure for judicial review is provided by 
another statute, in which case the review shall be 
under such other statute. Nothing in this Chapter 
shall prevent any person from invoking any judi- 
cial remedy available to him under the law to test 
the validity of any administrative action not made 
reviewable under this Article. 
§ 150B-44. Right to judicial intervention 

when decision unreasonably delayed. 

Unreasonable delay on the part of any agency or 
administrative law judge in taking any required 
action shall be justification for any person whose 
rights, duties, or privileges are adversely affected 
by such delay to seek a court order compelling 
action by the agency or administrative law judge. 
An agencv that is subject to Article 3 of this 
Chapter and is not a board or commission has 90 
days from the day it receives the official record in 
a contested case from the Office of Administrative 
Hearings to make a final decision in the case. 
This time limit may be extended by the parties or, 
for good cause shown, by the agency for an 
additional period of up to 90 days. An agency that 
is subject to Article 3 of this Chapter and is a 
board or commission has 90 days from the day it 
receives the official record in a contested case 
from the Office of Administrative Hearings or 90 
days after its next regularly scheduled meeting, 
whichever is longer, to make a final decision in 
the case. This time limit may be extended by the 
parties or, for good cause shown, by the agency 
for an additional period of up to 90 days. If an 
agency subject to Article 3 of this Chapter has not 
made a final decision within these time limits, the 
agency is considered to have adopted the adminis- 
trative law judge's recommended decision as the 
agency's final decision. Failure of an agency 
subject to Article 3A of this Chapter to make a 
final decision within 180 days of the close of the 
contested case hearing is justification for a person 
whose rights, duties, or privileges are adversely 
affected by the delay to seek a court order compel- 



ling action by the agency or, if the case was heard 
by an administrative law judge, by the administra- 
tive law judge. 

§ 150B-45. Procedure for seeking review; 
waiver. 

To obtain judicial review of a final decision 
under this Article, the person seeking review must 
file a petition in the Superior Court of Wake 
County or in the superior court of the county 
where the person resides. 

The person seeking review must file the petition 
within 30 days after the person is served with a 
written copy of the decision. A person who fails 
to file a petition within the required time waives 
the right to judicial review under this Article. For 
good cause shown, however, the superior court 
may accept an untimely petition. 
§ 150B-46. Contents of petition; copies served 
on all parties; intervention. 

The petition shall explicitly state what exceptions 
are taken to the decision or procedure and what 
relief the petitioner seeks. Within 10 days after 
the petition is filed with the court, the party 
seeking the review shall serve copies of the peti- 
tion by personal service or by certified mail upon 
all who were parties of record to the administrative 
proceedings. Names and addresses of such parties 
shall be furnished to the petitioner by the agency 
upon request. Any party to the administrative 
proceeding is a party to the review proceedings 
unless the party withdraws by notifying the court 
of the withdrawal and serving the other parties 
with notice of the withdrawal. Other parties to the 
proceeding may file a response to the petition 
within 30 days of service. Parties, including 
agencies, may state exceptions to the decision or 
procedure and what relief is sought in the re- 
sponse. 

Any person aggrieved may petition to become a 
party by filing a motion to intervene as provided in 
G.S. 1A-1. Rule 24. 

§ 150B-47. Records filed with clerk of superi- 
or court; contents of records; costs. 

Within 30 days after receipt of the copy of the 
petition for review, or within such additional time 
as the court may allow, the agency that made the 
final decision in the contested case shall transmit 
to the reviewing court the original or a certified 
copy of the official record in the contested case 
under review together with: (i) any exceptions, 
proposed findings of fact, or written arguments 
submitted to the agency in accordance with G.S. 
150B-36(a); and (ii) the agency's final decision or 
order. With the permission of the court, the 
record may be shortened by stipulation of all 



2079 



7:19 



NORTH CAROLINA REGISTER 



January 4, 1993 



GENERAL STATUTES OF NORTH CAROLINA 



parties to the review proceedings. Any party 
unreasonably refusing to stipulate to limit the 
record may be taxed by the court for such addi- 
tional costs as may be occasioned by the refusal. 
The court may require or permit subsequent 
corrections or additions to the record when deemed 
desirable. 
§ 150B-48. Stay of decision. 

At any time before or during the review proceed- 
ing, the person aggrieved may apply to the review- 
ing court for an order staying the operation of the 
administrative decision pending the outcome of the 
review. The court may grant or deny the stay in 
its discretion upon such terms as it deems proper 
and subject to the provisions of G.S. 1A-1. Rule 
65. 
§ 150B-49. New evidence. 

An aggrieved person who files a petition in the 
superior court may apply to the court to present 
additional evidence. If the court is satisfied that 
the evidence is material to the issues, is not merely 
cumulative, and could not reasonably have been 
presented at the administrative hearing, the court 
may remand the case so that additional evidence 
can be taken. If an administrative law judge did 
not make a recommended decision in the case, the 
court shall remand the case to the agency that 
conducted the administrative hearing. After 
hearing the evidence, the agency may affirm or 
modify its previous findings of fact and final 
decision. If an administrative law judge made a 
recommended decision in the case, the court shall 
remand the case to the administrative law judge. 
After hearing the evidence, the administrative law 
judge may affirm or modify his previous findings 
of fact and recommended decision. The administra- 
tive law judge shall forward a copy of his decision 
to the agency that made the final decision, which 
in turn may affirm or modify its previous findings 
of fact and final decision. The additional evidence 
and any affirmation or modification of a recom- 
mended decision or final decision shall be made 
part of the official record. 

§ 150B-50. Review by superior court without 
jury. 

The review by a superior court of agency deci- 
sions under this Chapter shall be conducted by the 
court without a jury. 
§ 150B-51. Scope of review. 

(a) Initial Determination in Certain Cases. In 
reviewing a final decision in a contested case in 
which an administrative law judge made a recom- 
mended decision, the court shall make two initial 
determinations. First, the court shall determine 
whether the agency heard new evidence after 



receiving the recommended decision. If the court 
determines that the agency heard new evidence, 
the court shall reverse the decision or remand the 
case to the agency to enter a decision in accor- 
dance with the evidence in the official record. 
Second, if the agency did not adopt the recom- 
mended decision, the court shall determine wheth- 
er the agency's decision states the specific reasons 
why the agency did not adopt the recommended 
decision. If the court determines that the agency 
did not state specific reasons why it did not adopt 
a recommended decision, the court shall reverse 
the decision or remand the case to the agency to 
enter the specific reasons. 

(b) Standard of Review. After making the 
determinations, if any, required by subsection (a), 
the court reviewing a final decision may affirm the 
decision of the agency or remand the case for 
further proceedings. It may also reverse or modi- 
fy the agency's decision if the substantial rights of 
the petitioners may have been prejudiced because 
the agency's findings, inferences, conclusions, or 
decisions are: 

(1) In violation of constitutional provisions; 

(2) In excess of the statutory authority or 
jurisdiction of the agency; 

(3) Made upon unlawful procedure; 

(4) Affected by other error of law; 

(5) Unsupported by substantial evidence 
admissible under G.S. 150B-29(a), 
150B-30. or 150B-31 in view of the 
entire record as submitted; or 

(6) Arbitrary or capricious. 

§ 150B-52. Appeal; stay of court's decision. 
A party to a review proceeding in a superior 
court may appeal to the appellate division from the 
final judgment of the superior court as provided in 
G.S. 7A-27. Pending the outcome of an appeal, 
an appealing party may apply to the court that 
issued the judgment under appeal for a stay of that 
judgment or a stay of the administrative decision 
that is the subject of the appeal, as appropriate. 

Article 5. 
Publication of Administrative Rules. 

Repealed. 



7:19 



NORTH CAROLINA REGISTER 



January 4, 1993 



2080 



EXECUTIVE ORDER 



EXECUTIVE ORDER NUMBER 183 

AMENDING AND REISSUING THE PROVISIONS 

OF EXECUTIVE ORDER NOD3ER 175 

Hurricane Andrew relief efforts necessitate another temporary period of exemption from weight restrictions 
on vehicles transporting supplies and equipment through North Carolina from the areas of disaster caused by 
Hurricane Andrew. 

Pursuant to the authority vested in me as Governor of North Carolina under the constitution and laws of this 
State. IT IS ORDERED: 

Executive Order Number 175 dated August 28. 1992 is reissued with the following amendments: 

Section 1. 

1 4 j Upon entering North Carolina, the vehicles will stop at the first available vehicle weight station and 
produce identification sufficient to establish that its load was used for the Hurricane Andrew relief 
effort. All other safety restrictions apply. If returning vehicles are loaded with some other 
backhaul, all normal weight and permit restrictions apply. 

Section 2. 

The S50.00 fee listed in N.C.G.S. 105 - 449.49 for a temporary trip permit is waived for the vehicles 
described above. The penalties described in N.C.G.S. 20 - 382 concerning insurance registration 
are waived also. Finally, no quarterly fuel tax is required because the exception in N.C.G.S. 105 
- 449.45 (a)(1) applies. 

Section 3 is deleted. 

This Order is effective December 16. 1992 and shall remain in effect until December 23. 1992. 

Done in Raleish. North Carolina, this the 7th dav of December. 1992. 



t 



2081 7:19 NORTH CAROLINA REGISTER January 4, 1993 



IN ADDITION 



NORTH CAROLINA WILDLIFE RESOURCES COMMISSION 

PROCLAMATION 

Charles R. Fullwood, Executive Director, North Carolina Wildlife Resources Commission, acting 
pursuant to North Carolina General Statute §113-292 (cl) and authority duly delegated by the Wildlife 
Resources Commission, hereby declares that the season for harvesting striped bass by hook-and-line shall 
remain closed in all waters of the Roanoke River Striped Bass Management Area until 12:00 p.m. 28 February 
1993. 

The Roanoke River Striped Bass Management Area is defined as the inland and joint fishing waters 
of the Roanoke River and its tributaries, extending from its mouth to Roanoke Rapids Dam, including the 
Cashie, Middle, and Eastmost rivers and their tributaries. 

This Proclamation shall be effective at 12:01 a.m. 1 January 1993 and shall remain in effect until 
12:00 p.m. 28 February 1993 or until a new proclamation opening the described waters or portions thereof 
for striped bass fishing is issued. 

NOTES: 

a) This Proclamation is issued under the authority of N.C.G.S. §113-132; 113-134; 113-292; 
113-304; and 113-305. 

b) All striped bass regardless of condition taken subsequent to the effective date and time of this 
Proclamation shall be immediately returned to the waters where taken and no striped bass 
may be possessed. 

c) Any person who violates this Proclamation also violates applicable law and is subject to the 
sanctions provided by law. 



NORTH CAROLINA WILDLIFE RESOURCES COMMISSION 



by 



Charles R. Fullwood 
Executive Director 



7:19 



NORTH CAROLINA REGISTER 



January 4, 1993 



2082 



PROPOSED RULES 



TITLE 10 - DEPARTMENT OF 
HUMAN RESOURCES 

Notice is hereby given in accordance with G.S. 
150B-21.2 that the DHR/Division of Medical 
Assistance intends to amend rules cited as 10 
NCAC26B .01 19 and .0121. 

1 he proposed effective date of this action is April 
1. 1993. 

1 he public hearing will he conducted at 1:30 
p.m. on February 5. 1993 at the North Carolina 
Division of Medical Assistance, 1985 Umstead 
Drive. Room 132. Raleigh, NC 27603. 

ixeason for Proposed Action: 
10 NCAC 26B .0119 - This amendment will bring 
Medicaid personal care services provider qualifica- 
tions in line with State licensure requirements for 
providers of in-home aide services under the Home 
Care Licensure Act. 

10 NCAC 26B .0121 - This change is necessary to 
bring Medicaid private duty nursing provider 
qualifications in line with State licensure require- 
ments for providers of nursing services under the 
Home Care Licensure Act. 

(comment Procedures: Written comments con- 
cerning these amendment must be submitted by 
February 5. 1993. to: Division of Medical Assis- 
tance. 1985 Umstead Drive. Raleigh. NC 27603 
ATTN' Clarence Ervin. APA Coordinator. Oral 
comments may be presented at the hearing. In 
addition, a fiscal impact statement is available 
upon written request from the same address. 

CHAPTER 26 - MEDICAL ASSISTANCE 

SUBCHAPTER 26B - MEDICAL 
ASSISTANCE PROVIDED 

SECTION .0100 - GENERAL 

.0119 PERSONAL CARE SERVICES 

(a) The Division of Medical Assistance will 
cover personal care services in accordance with 
federal law. The provision of personal care 
services must be physician authorized and must 
meet the following criteria: 

( 1 ) The recipient of the service must have 



(2) 
(3) 



a medical diagnosis that warrants a 
physician "s care and that recipient must 
be under the direct and ongoing care of 
the physician prescribing PCS. 
The recipient's medical condition must 
be stable at maintenance level. 
There must be a medical necessity for 
the provision of personal care services. 



(b) Agcnck 



■ hieh 



4^ 



ics xMiicn iiuu ae ei 
crs of service include: — eountv 



provid 



eA 



health departments: eountv department s of s oci 
services: certified home health agencies: hospice 
agencies enrolled in Medicaid: the State Divi s ion 
of Services — for the — Blind: — agencie s — accredited 



* 



rough — fee — Community — Health — Accreditation 
Program care organization s providing paraprofe s 



4- 



jcrviecs: agencies accredited bv the Joint 



Commission on Accreditation of Healthcare Orga 



-tht 



nization s — fef- — meeting — their — Standard s — fef- 
Accrcditation of Home Care and s pecific quality 
s tandard s — fef — provider s — of personal — e-afe — aftd 
support s ervice s : agencie s accredited bv the North 
Carolina Accreditation Commi ss ion for In Home 
.Aide — Services: — and — agencie s — approved — by — tfre 
National HomeCaring Council as 



s — council u s — meeting — B asic 
National Standards for Home - maker Home Health 
Aide Service s . An enrolled provider must be a 
State licensed home care agency located within 
North Carolina that js approved in its license to 
provide in-home aide services. 



Authority G.S. 108A-25(b>: S.L. 1985, 
86: 42 C.F.R. 440.170(f). 



479, 



.0121 PRIVATE DUTY NURSING 

(a) Medically necessary private duty nursing 
(PD\) services are provided when they are pre- 
scribed by a physician and prior approved by the 
Division of Medical Assistance or its designee. 

(b) A patient must reside in the patienfs private 
residence to receive PDN services. Recipients 
who are in domiciliary care facilities (such as rest 
homes, group homes, family care homes, and 
similar settings) and those who are in hospitals, 
nursing facilities, intermediate care facilities for 
the mentally retarded, rehabilitation centers, and 
other institutional settings are not eligible for this 
service. PDN services are not covered while an 
individual is being observed or treated in a hospital 
emergency room or similar environment. 

(c) Private duty nursing services are considered 
medically necessary when the person must require 
substantial and complex continuous nursing care by 
a licensed nurse. Professional judgment and a 



2083 



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NORTH CAROLINA REGISTER 



January 4, 1993 



CUutUatKiM 



PROPOSED RULES 



thorough evaluation of the medical complexity and 
psychosocial needs of the patient are involved in 
determining the need for PDN. The following 
situations represent the usual types of cases that 
may require PDN, though the list is not meant to 
be all inclusive: 

(1) Patient requires prolonged intravenous 
nutrition or drug therapy with needs 
beyond those covered by infusion thera- 
py services. 

(2) Patient is dependent on a ventilator for 
prolonged periods. 

(3) Patient is dependent on other device- 
based respiratory support, including 
tracheostomy care, suctioning, and 
oxygen support. 

(d) This service is only approvable based on the 
need for PDN services in the 

patient's private residence. An individual with a 
medical condition that necessitates this service 
normally is unable to leave the home without being 
accompanied by a licensed nurse and leaving the 
home requires considerable and taxing effort. An 
individual may utilize the approved hours of 
coverage outside to his residence during those 
hours when the individual's normal life activities 
take the patient out of the home. The need for 
nursing care to participate in activities outside of 
the home is not a basis for authorizing PDN 
services or expanding the hours needed for PDN 
services. 

(e) A person may not receive Personal Care 
Services. Skilled Nursing Visits, and Home Health 
Aide Services reimbursed by Medicaid during the 
same hours of the day as PDN services. 

(f) The patient's spouse, child, parent, grandpar- 
ent, grandchild, or sibling, including correspond- 
ing step and in-law relationship may not be em- 
ployed by the provider agency when reimbursed 
by Medicaid to provide PDN services to the 
patient. 

(g) Medicaid payments for PDN are made only 
to agencies enrolled with the Division of Medical 
Assistance as providers for the service. An agency 
mu s t be one of the following to be enrolled to 
provide thi s service: 

f-H A Medicare certified homo health agon 

cy located within North Carolina. 

(3) A State licen s ed home health agency 

l ocated within North Carolina. 

(3-) An agency with a North Carolina office 

that i s accredited in the provision of in 
home nursing care by either the Joint 
Commi s sion on Accreditation of Health 
Care Organizations (JCAHO) or the 



National League for Nur s ing (NLN). 
An enrolled provider must be a State licensed 
home care agency located within North Carolina 
that is approved in its license to provide Nursing 
Services. 

Authority G.S. 108A-25(b); 108A-54;42 C.F.R. 
440. 80. 

l\otice is hereby given in accordance with G.S. 
I50B-21.2 that the DHR/Division of Medical 
Assistance intends to amend rule cited as 10 
NCAC 26D .0012 with changes from the proposed 
text noticed in the Register , Volume 7, Issue 12, 
page 1156. 

1 he proposed effective date of this action is April 
1. 1993. 

Reason for Proposed Actions: The rule clarifies 
that the phrase "date of payment" and addresses 
Medicaid claims for which payment was denied. 

Lsomment Procedures: Written comments con- 
cerning this amendment must be submitted by 
February 4, 1993, to: Division of Medical Assis- 
tance. 1985 Umstead Drive, Raleigh, NC 27603 
ATTN: Clarence Ervin, APA Coordinator. In 
addition, a fiscal impact statement is available 
upon written request from the same address. 

tLditor's Note: An agency may not adopt a rule 
that differs substantially from the text of a pro- 
posed rule published in the Register, unless the 
agency publishes the text of the proposed differ- 
ent rule and accepts comments on the new text 
for at least 30 days after the publication of the 
new text. 

SUBCHAPTER 26D - LIMITATIONS ON 
AMOUNT: DURATION: AND SCOPE 

.0012 TIME LIMITATION 

(a) To receive payment, claims must be fil e d 
e ither received for processing : 

( 1 ) Within 365 days of the date of service 
for services other than inpatient hospi- 
tal, home health or nursing home ser- 
vices; or 

(2) Within 365 days of the date of 



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2084 



PROPOSED RULES 



discharge for inpatient hospital services 
and the last date of service in the month 
for home health and nursing home 
services not to exceed the limitations as 
specified in 42 C.F.R. 447.45; or 
(3) Within 180 days of the Medicare or 
other third party payment, or within 
180 days of Final denial, when the date 
of the third party payment or denial 
exceeds the filing limits in Paragraphs 
( 1 ) or (2) of this Rule^ except that the 
time limit may not be waived under this 
Paragraph when the claim is denied 
because jt was not submitted to the 
third party timely, the service was not 
a covered service by the third party . the 
individual was not enrolled with the 
third party or the claim was paid or 
denied at an earlier date. 

(b) Providers must file requests for payment 
adjustments or requests for reconsideration of a 
denied claim no later than 18 months after the date 
of payment or denial of a claim, or adjustments 
wil l not be made. 

(c) The time limitation specified in (a) of this 
Rule may be waived by the Division of Medical 
Assistance when <m — d e lay — m an eligibility 
determination^ has — made — rt — impossible — for the 
provider to file the claim within the 365 days 
provided for in (a) of this Rule correction of an 
administrative error [n determining eligibility, 
application of a court order or hearing decision 
grants eligibility with less than 60 days for 
providers to submit claims for eligible dates of 
service provided the claims js received for 
processing within 180 days after the date the 
county department of Social Services approves the 
eligibility . 

(d) In cases where claims or adjustments were 
not filed within the time limitations specified in (a) 
and (b) of this Rule, and the provider shows 
failure to do so was beyond his control, he may 
request a reconsideration review by the Director of 
the Division of Medical Assistance. The Director 
of Medical Assistance is the final authority for 
reconsideration reviews. If the provider wishes to 
contest this decision, he may do so by filing a 
petition for a contested case hearing in 
conformance with G.S. 150B-23. 

Authority G.S. 108A-25(b); 42 C.F.R. 447.45. 



TITLE 15A - DEPARTMENT OF 



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PROPOSED RULES 



ENVIRONMENT, HEALTH, AND 
NATURAL RESOURCES 

IS otice is hereby given in accordance with G.S. 150B-21.2 that the Environmental Management Commission 
intends to amend rule cited as 15A NCAC 2D . 1002. 

1 he proposed effective date of this action is June 1, 1993. 

1 he public hearing will be conducted at 7:00 p.m. on February 3, 1993 at the Guilford Count)- Courthouse, 
Courtroom 2A. 210 South Eugene Street, Greensboro, NC. 

i\.eason for Proposed Action: To remove requirement for an inspection/maintenance program in Davidson 
and Randolph Counties. 

Lsomment Procedures: All persons interested in this matter are invited to attend the public hearing. Any 
person desiring to comment for more than three minutes at the public hearing is requested to submit a written 
statement for inclusion in the record of proceedings. Tlie hearing officer may limit oral presentation lengths 
to five minutes if may people want to speak. Tlie record of proceedings will remain open until March 1 . 1993. 
to receive additional written statements. To be included, the statement must be received by the Department 
by March 1. 1993. 

Comments should be sent to and additional information concerning the hearing or the proposals may be 
obtained by contacting: Mr. Thomas C. Allen. Division of Environmental Management , P.O. Box 29535. 
Raleigh. North Carolina 27626-0535. (919) 733-1489. 

tLditor's Note: Tliis Rule was filed as a temporary amendment to delete Davidson County in Paragraph 
(a) and the addition of Paragraph (c). Tlie deletion of Randolph County in Paragraph (a) was not a part 
of the temporary filing. Tlie effective date of the temporary amendment is January 1, 1993 for a period 
of 180 days or until the permanent rule becomes effective, whichever is sooner. 

CHAPTER 2 - ENVIRONMENTAL MANAGEMENT 

SUBCHAPTER 2D - AIR POLLUTION CONTROL REQUIREMENTS 

SECTION .1000 - MOTOR VEHICLE EMISSION CONTROL STANDARD 

.1002 APPLICABILITY 

(a) This Section is applicable to all 1975 and later gasoline-powered motor vehicles, except motorcycles and 
excluding the current model year, that are required to be registered by the North Carolina Division of Motor 
Vehicles in the counties listed in Paragraph (b) of this Rule. 

(b) The emission standards will become effective in the following counties on the dates indicated below: 

County Effective Date 



lecklenburg 


April 1 


1991 


Wake 


April 1 


1991 


Forsyth 


July 1 


1991 


Guilford 


July 1 


1991 


Durham 


July 1 


1992 


Gaston 


July 1 


1992 


Davidson 


January 1 


-WS£ 



7:19 NORTH CAROLINA REGISTER January 4, 1993 2086 



PROPOSED RULES 



( 'abarrus 

Randolph 

Orange 

Union 



January 1, 1993 
July 1. 1993 



July 1 
July 1 



1993 
1993 



(c) If the United States Environmental Protection Agency does not redesignate Davidson, Forsyth, and 
Guilford Counties and the portion of Davie County that is nonattainment for ozone as attainment areas for 
ozone, then emission standards and requirements of this Section shall become effective in Davidson and 
Randolph Counties within six months of formal notification by EPA. 



Statutory Authority 
143-215. 107(a)(7). 



G.S. 20-128.2(a): 143-215. 3(a)(1): 143-215. 107(a)(3); 143-215. 107(a)(6); 



tion. P. O. Box 27687. Raleigh, NC 27611-7687. 
Written comments will be accepted until February 
3. 1993. Any person requesting information 
concerning these rules should contact Richard M. 
Fry at 919/571-4141. 



I\ otice is hereby given in accordance with G.S. 
150B-21.2 that the EHNR - Radiation Protection 
Commission intends to adopt rules cited as 15.A 
NCAC 11 .0117. amend rules cited as 15A NCAC 
11 .0101 - .0102. .0105 - .0108. .0111. .0113 - 
.0115. .0201. .0205. .0207. .0210. .0212 - .0214. 
.0303 - .0305. .0318. .0321. .0324 - .0326. .0337 
- .0338. .0343 - .0346. .0352. .0501. .0507. 
.0510. .0518. .0602. .0605 - .0606. .0701. .0703. 
.0902. . 1001.. 1006. .1102- .1104. . 1202 - . 1203. 
.1205. .1210. .1215. .1218. .1220- .1221. .1223. 
. 1227. . 1229. . 1239 - . 1240. . 1306. . 1308 - . 1310. 
.1313 and repeal rule cited as 15A NCAC 11 
. 0336 

1 he proposed effective date of this action is May 
3. 1993. 

Instructions on How to Demand a Public Hearing 
(must be requested in writing within 15 days of 
notice): Any person requesting that the Division of 
Radiation Protection hold a public hearing on 
these rules must submit a written request by Janu- 
ary 19. 1993. Die request must be submitted to 
Richard M. Fry, Deputy Director, Division of 
Radiation Protection, P. O. Bo.x 27687. Raleigh. 
NC 27611-7687. 

Keason for Proposed Action: Corrects misspelled 
words; removes obsolete Subparagraph numbers; 
corrects agency telephone number; adopts federal 
citations by reference in Rule .0117; and Rule 
.0336 is being repealed as information is now 
contained in Rule .0117. 

Comment Procedures: Written comments should 
be submitted to the Division of Radiation Protec- 



CHAPTER 1 1 - RADIATION PROTECTION 
SECTION .0100 - GENERAL PROVISIONS 

.0101 SCOPE 

(a) Except as otherwise specifically provided 
these Regulation s Rules apply to all persons who 
receive, possess, use, transfer, own or acquire any 
source of radiation within the State of North 
Carolina. 

(b) Nothing in these Regulations Rules shall 
apply to any person to the extent any person is 
subject to regulation by the United States Nuclear 
Regulatory Commission. 

(c) Regulation by the State of North Carolina of 
source material, byproduct material, and special 
nuclear material in quantities not sufficient to form 
a critical mass is subject to the provisions of an 
agreement made between the Governor of this state 
and the United States Nuclear Regulatory Commis- 
sion under provisions of Public Law 86-373, as 
amended, and to 10 CFR Part 150. 



Statutory 
104E-10. 



Authority G.S. 104E-2; 104E-7; 



.0102 COMPLIANCE WITH LAWS 

Nothing in these Regulations Rules shall relieve 
any person of responsibility for complying with 
other pertinent North Carolina laws, rules and 
regulations. 

Statutory Authority G.S. 104E-7. 

.0105 OTHER DEFINITIONS 

Definitions of certain other words and phrases as 
used in these Regulation s Rules are set forth in 



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PROPOSED RULES 



Sections .0500, .0600, .0800, .1200, .1300, and 
.1400, and .1500 of this Chapter. 

Statutory Authority G.S. 104E-7. 

.0106 EXEMPTIONS 

(a) The agency may, upon application therefore, 
grant individual exemptions or exceptions from the 
requirements of these Regulation s Rules as it 
determines are authorized by law and will not 
result in undue hazard to public health and safety 
or property. 

(b) Except as otherwise provided in this Rule, 
common and contract or other carriers, freight 
forwarders, and warehousemen, who are subject to 
the rules and regulations of the U.S. Postal Service 
(39 CFR Parts 14 and 15), are exempt from these 
Regulations Rules to the extent that they transport 
or store sources of radiation in the regular course 
of their carriage for another or storage incident 
thereto. Common, contract, or other carriers who 
are not exempt pursuant to this Rule are subject to 
the provisions of Rule .0316 of this Chapter. 
Notwithstanding these exemptions, common, 
contract or other carriers are required to comply 
with the provisions of Rule .0316(c) of this 
Chapter to the extent that these carriers are 
transporting spent nuclear fuel, as defined in Rule 
.0316(c) of this Chapter, upon the highways of 
North Carolina. 

(c) Any U.S. Department of Energy contractor 
or subcontractor and any U.S. Nuclear Regulatory 
Commission contractor or subcontractor of the 
following categories operating within this state is 
exempt from these Regulations to the extent that 
the contractor or subcontractor under his contract 
receives, possesses, uses, transfers or acquires 
sources of radiation: 

( 1 ) prime contractors performing work for 
the U.S. Department of Energy at U.S. 
government-owned or controlled sites, 
including the transportation of sources 
of radiation to or from such sites and 
the performance of contract services 
during temporary interruptions of such 
transportation; 

(2) prime contractors of the U.S. 
Department of Energy performing 
research in. or development, 
manufacture, storage, testing or 
transportation of, atomic weapons or 
components thereof; 

(3) prime contractors of the U.S. 
Department of Energy using or 
operating nuclear reactors or other 



nuclear devices in a United States 
government-owned vehicle or vessel; 
and 
(4) any other prime contractor or 
subcontractor of the U.S. Department 
of Energy or of the U.S. Nuclear 
Regulatory Commission when the 
agency and the U.S. Nuclear 
Regulatory Commission jointly 
determine that: 

(A) the exemption of the prime contractor 
or subcontractor is authorized by law, 

(B) that under the terms of the contract or 
subcontract, there is adequate 
assurance that the work thereunder 
can be accomplished without undue 
risk to the public health and safety. 

Statutory Authority G.S. 104E-2; 104E-7;104E-15. 

.0107 INSPECTIONS 

Each licensee and registrant shall, upon 
reasonable notice, make available to the agency 
for inspection records maintained pursuant to 
provisions of these Regulations Rules . 

Statutory Authority G.S. 104E-7; 104E-ll(a), 

.0108 ADDITIONAL REQUIREMENTS 

(a) The agency may, by license condition, 
registration condition, or order, when not in 
conflict with any law, impose upon any specific or 
general licensee or registrant such requirements in 
addition to those established in these Regulations 
Rules as it deems appropriate or necessary to 
minimize danger to public health, safety or 
property. Such additional requirements are subject 
to appeal procedures contained in Section 15A 
NCAC IB .0200. 

(b) The Commission may by rule or regulation 
require radioactive material licensees to procure 
and file with the department such bond, insurance 
or other security as the Commission deems 
necessary to protect the state from costs for 
emergency response and perpetual maintenance. 

Statutory Authority G.S. 104E-7; I04E-I8. 

.0111 COMMUNICATIONS 

(a) Except as provided in Paragraph (b) of this 
Rule, all Att communications and reports 
concerning these Rules, and applications filed 
thereunder, shall be mailed to the agency at 
Division of Radiation Protection, P.O. Box 27687, 
Raleigh. North Carolina 2761 1-7687 or delivered 



7:19 



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2088 



PROPOSED RULES 



to the agency at its office located at 3825 Barrett 
Drive. Raleigh, North Carolina 27609-7221. 

(b) Except as specifically instructed otherwise 
by the agency, immediate telephone notification 
and reports required by the rules in this Chapter 
shall be directed to (919) 571-4141 from 8:00 a.m. 
to 5:30 p.m. on workdays. 

Statutory Authority G.S. 104E-7. 

.01 13 CLASSIFICATION OF RADIOACTIVE 
MATERIAL 

For a single radionuclide of known identity, the 
values of A, and A 2 used for determining Type A 
quantity in the Rules rules of this Chapter are 
taken from Appendix A of 10 CFR 71 as revised 
at 48 Federal Register 35600. August 5, 1983, and 
corrections at 48 Federal Register 38449, August 
24, 1983. 

Statutory Authority G.S. 104E. 

.0114 TESTS FOR SPECIAL FORM 

Special form radioactive material as defined in 
Rule .0104 (56) of this Section must satisfactorily 
pass the following tests: 

( 1 ) a free drop through a distance of 30 feet 
onto a flat essentially unyielding horizon- 
tal surface, striking the surface in such a 
position as to suffer maximum damage; 

(2) impact of the flat circular end of a 
one-inch diameter steel rod weighing 
three pounds, dropped through a distance 
on a sheet of lead, of hardness number 
3.5 to 4.5 on the Vickers scale, and not 
more than one inch thick supported by a 
smooth essentially unyielding surface; 

(3) heating in air to a temperature of 1,475° 
F. and remaining at that temperature for 
a period often minutes; 

(4) immersion for 24 hours in water at room 
temperature at pH 6 to pH 8. with a 
maximum conductivity often micromhos 
per centimeter. 

Statutory Authority G.S. 104E-15. 

.0115 RECORDS 

Each licensee and registrant shall maintain 
records showing the receipt, transfer, and disposal 
of all sources of radiation. Additional record 
requirements are specified elsewhere in these 
Regulation:. ! Rules . 

Statutory Authority G.S. 104E-7; 104E-12(a). 



.0117 FEDERAL RULES INCORPORATED 
BY REFERENCE 

(a) For the purpose of the rules in this Chapter, 
the following federal regulations are hereby incor- 
porated by reference including any subsequent 
amendments and editions: 



ill 

ill 
ill 

Ml 

(5} 

161 



ill 
181 



Appendix A, Appendix B and Appendix 

C to 10 CFR Parts 20.1001 - 20.2401; 

K) CFR Part 3_K JO CFR Part 32 and 

JO CFR Part 40, 

10 CFR Part 61. JO CFR Part 70, K) 

CFR Part 71, 10 CFR Part 73, 10 CFR 

Part 110, 10 CFR Part 140 and 10 CFR 

Part 150; 

2J. CFR .Part 1010, 2J. CFR Part 1020 

and 21 Cf_R Part 1040; 

39 CFR Part 14 and 39 CFR Part 15; 
Postal Service Manual (Domestic Mail 
Manual) Section 124.3 [incorporated by 
reference in 39 CFR Section 111.111; 

40 CFR Part 261; and 
49 CFR Parts 100-189. 



(b) The regulations incorporated by reference jn 
Paragraph (a) of this Rule are available for inspec- 
tion at the Department of Environment, Health, 
and Natural Resources, Division of Radiation 
Protection at the address listed jn Rule .0111 of 
this Section. Except as noted in Subparagraph 
(b)( 1 ) of this Rule, copies of the regulations 
incorporated by reference jn Paragraph (a) of this 
Rule may be obtained from the Superintendent of 
Documents, U.S. Government Printing Office, 



20402 at a cost as follows: 



Washington. D.C 

( 1 ) $5.00 for the appendixes listed jn Sub- 
paragraph (a)( 1 ) of this Rule, available 
from the Division of Radiation Protec- 
tion at the address listed m Rule .0111 
of this Section; 

(2) $25.00 for the regulations listed in 
Subparagraph (a)(2) of this Rule jn a 
volume containing 10 CFR Parts 0-50; 

(3) $18.00 for the regulations listed jn 
Subparagraph (a)(3) of thjs Rule jn a 
volume containing 10 CFR Parts 51- 
199; 

(4) $18.00 for the regulations listed jn 
Subparagraph (a)(4) of this Rule jn a 
volume containing 21 CFR Parts 800- 
1299; 

(5) $16.00 for the regulations listed jn 
Subparagraph (a)(5) of this Rule jn a 
volume containing 39 CFR; 

(6) $36.00 for the manual listed jn 
■Subparagraph (a)(6) of this Rule: 

(7) $31.00 for the regulations listed jn 



2089 



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January 4, 1993 



PROPOSED RULES 



Subparagraph (a)(7) of this Rule in a 
volume containing 40 CFR Parts 260- 
299; and 
(8) for the regulations listed in 
Subparagraph (a)(8) of this Rule: 

(A) $23.00 for a volume containing 49 
CFR Parts 100-177; and 

(B) $17.00 for a volume containing 49 
CFR Parts 178-199. 

Statutory Authority G.S. 104E-7; 104E-15(a); 
150B-21.6. 

SECTION .0200 - REGISTRATION OF 

RADIATION MACHINES: FACILITIES 

AND SERVICES 

.0201 PURPOSE AND SCOPE 

(a) This Section provides for the registration of 
radiation machines, radiation machine facilities and 
persons who provide other radiological services. 

(b) For purposes of this Section, "facility" 
means the location at which one or more radiation 
machines are installed or located within one 
building, vehicle, or under one roof and are under 
the same administrative control. 

(c) In addition to the requirements of this 
Section, all registrants are subject to the provisions 
of the other sections of this Chapter. 

(d) Special requirements for registration of 
particle accelerators are provided in Section .0900 
of this Chapter and are in addition to the 
requirements m of this Section. 

(e) In addition to the requirements of this 
Section, all registrants are subject to the annual fee 
provisions contained in Section .1100 of this 
Chapter. 

Statutory Authority G.S. 104E-7; 104E-9(8); 
104E-19(a). 

.0205 APPLICATION FOR REGISTRATION 
OF SERVICES 

(a) Each person who is engaged in the business 
of installing or offering to install radiation 
machines and machine components or is engaged 
in the business of furnishing or offering to furnish 
any equipment services listed in Paragraph (d) of 
this Rule in this state, to any agency licensee or 
registrant, shall apply for registration of such 
services with the agency within 30 days following 
the amended effective date of this Rule or 
thereafter prior to furnishing or offering to furnish 
any of these services. 

(b) Application for registration shall be 



completed on appropriate form(s) provided by the 
agency and shall contain all information required 
by the agency as indicated on the form and 
accompanying instructions. This information shall 
include: 

(1) the name, address and telephone 
number of: 

(A) the individual or the company to be 
registered; 

(B) the owner(s) of the company; 

(2) the description of the services to be 
provided; 

(3) the name, training and experience of 
each person who provides services 
specified in Paragraph (d) of this Rule; 

(4) the date of the application and the 
signature of the person responsible for 
the company; and 

(5) any additional information the agency 
determines to be necessary for 
evaluation of the application for 
registration. 

(c) Each person applying for registration under 
Paragraph (a) of this Rule shall certify that he has 
read and understands the requirements of the Rules 
rules in this Chapter. 

(d) For the purpose of this Section, equipment 
services are: 

( 1 ) direct sale and transfer of radiation 
machines and machine components to 
end users; 

(2) installation or servicing of radiation 
machines and associated radiation 
machine components; 

(3) diagnostic radiographic facility and 
shielding design; 

(4) diagnostic fluoroscopic facility and 
shielding design; 

(5) diagnostic area radiation survey, e.g.. 
shielding evaluation; 

(6) radiation instrument calibration; 

(7) therapeutic facility and shielding 
design, area radiation survey or 
calibration; 

(8) personnel dosimetry services; 

(9) general health physics consulting, e.g., 
independent diagnostic radiation output 
measurements, dose analysis, design of 
safety programs and radiation safety 
training programs, non-healing arts 
facility and shielding design and area 
radiation surveys; and 

(10) such other equipment services which 
can affect compliance with these Rules 
by a licensee or registrant, as 



7:19 



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PROPOSED RULES 



determined by the agency, 
(e) Applicants for registration of services are 
subject to the applicable requirements of Rules 
.0213 and .0214 of this Section. 

Statutory Authority G.S. 104E-7. 

.0207 ISSUANCE OF NOTICE OF 
REGISTRATION 

(a) The agency shall issue a notice of 
registration upon a determination that an applicant: 

(1) is qualified by reason of education, 
training and experience; 

(2) has adequate facilities and equipment; 

(3) has established an adequate radiation 
protection program appropriate to the 
registered activities; and 

(4) meets the applicable requirements in 
this Chapter. 

(b) The agency may incorporate in the notice of 
registration at the time of issuance or thereafter by 
amendment or order, such additional requirements 
and conditions with respect to the registrant's 
receipt, possession, use and transfer of radiation 
machines as the agency deems appropriate or 
necessary for compliance with the rules in this 
Chapter. Such additional requirements are subject 
to appeal under 15A NCAC IB .0200. 

(c) The agency may refuse to grant a 
registration required in Rules .0203 and .0205 of 
this Section to any applicant who does not possess 
adequate qualifications or equipment or satisfy the 
applicable requirements in this Chapter; provided 
that, before any order is entered denying an 
application for registration, the agency shall give 
notice and grant a hearing as provided in Chapter 
150B of the North Carolina General Statues 
Statutes, 

Statutory Authority G.S. 104E-7. 

.0210 OTHER PROHIBITED ACTIVITIES 

(a) No person registered pursuant to Rule .0205 
of this Section for x-ray sales or installations shall 
make. sell, lease, transfer, lend, assemble, or 
install radiation machines or equipment used in 
connection with such machines unless such 
machines and equipment when placed in operation 
shall meet the applicable requirements of these 
Regulations Rules . 

(b) No person, in any advertisement, shall refer 
to the fact that he or his facility is registered with 
the agency pursuant to the provisions of Rule 
.0203 or .0205 of this Section and no person shall 
state or imply that any activity under such 



registration has been approved by the agency. 

(c) No person registered pursuant to Rule .0205 
of this Section shall install radiation machines 
which are subject to provisions of Section .0600 of 
this Chapter unless the registrant first determines 
that the agency has issued written 
acknowledgement of receipt of any facility and 
shielding design required in Rule .0603 of this 
Chapter. 

Statutory Authority G.S. 104E-7; 104E-20. 

.0212 MODIFICATIONS: REVOCATION: 
TERMINATION OF REGISTRANTS 

(a) The terms and conditions of all registrations 
are subject to amendment, revision or modification 
and all registrations are subject to suspension or 
revocation by reason of: 

( 1 ) amendments to the Act; 

(2) rules adopted pursuant to provisions of 
the Act; or 

(3) orders issued by the agency pursuant to 
provisions of the Act and rules adopted 
pursuant to provisions of the Act. 

(b) Any registration may be revoked, suspended 
or modified in whole or in part: 

( 1 ) for any material false statement in the 
application or in any statement of fact 
required by provisions of this Section; 

(2) because of conditions revealed by: 

(A) the application; 

(B) any statement of fact; 

(C) any report, record, inspection or other 
means, which would warrant the 
agency to refuse to grant a 
registration on original application; or 

(3) for violations of, or failure to observe 
any of the terms and conditions of the 
Act, the registration, the Rule s rules of 
this Chapter, or order of the agency. 

(c) Except in cases of willfulness or those in 
which the public health, interest or safety requires 
otherwise, prior to the institution of proceedings 
for modification, revocation or suspension of a 
registrant, the agency shall: 

( 1 ) call to the attention of the registrant in 
writing the facts or conduct which may 
warrant these actions, and 

(2) provide an opportunity for the 
registrant to demonstrate or achieve 
compliance with all lawful 
requirements. 

(d) Before any order is entered suspending, 
revoking or modifying a registration, the agency 
shall give notice and grant a hearing as provided in 



2091 



7:19 



NORTH CAROLINA REGISTER 



January 4, 1993 



PROPOSED RULES 



Chapter 150B of the North Carolina General 
Statutes. 

(e) The agency may terminate a registration 
upon written request submitted by the registrant to 
the agency. 

Statutory Authority- G.S. 104E-7. 

.0213 ADDITIONAL REQUIREMENTS: 
REGISTERED SERVICES 

(a) An applicant for registration of diagnostic 
area radiation survey, diagnostic radiation output 
measurements or therapeutic calibration services 
pursuant to Rule .0205 of this Section shall meet 
the following additional requirements: 

( 1 ) The applicant shall have adequate 
radiation survey and radiation 
measurement equipment appropriate to 
the services requested for authorization. 

(2) The applicant shall ensure that the 
equipment in Subparagraph (a)(1) of 
this Rule is calibrated at least every 12 
months by persons registered to provide 
such services pursuant to Rule .0205 of 
this Section, except as provided in 
Subparagraph (a)(3) of this Rule. The 
agency may approve less frequent 
calibration of equipment used for 
therapy calibration, provided the 
applicant satisfies the agency that the 
proposed frequency and procedures will 
provide equivalent or better assurance 
of proper calibration. 

(3) The applicant may perform the 
equipment calibrations required in 
Subparagraph (a)(2) of this Rule 
provided that: 

(A) such calibrations are currently 
traceable to the National Institute of 
Standards and Technology; 

(B) the calibration procedures are 
approved by the agency; 

(C) the radiation sources used for such 
calibration are licensed or registered 
as required by the Rule s rules in this 
Chapter; and 

(D) the equipment is labeled to indicate 
the date of calibration and records of 
the calibration are maintained. 

(4) The applicant shall submit, for approval 
by the agency: 

(A) a description of the procedures that 
will be utilized in performing area 
radiation surveys including a list of all 
guides and references to the 



employed; 

(B) a copy of all forms, reports and 
documents that will be supplied to 
customers; 

(C) samples of three different types of 
surveys; 

(D) samples of three reports of diagnostic 
radiation output measurements; and 

(E) samples of three therapeutic 
calibration reports. 

(b) An applicant for registration of services 
pursuant to Rule .0205 of this Section who 
proposes to provide diagnostic radiographic, 
fluoroscopic and therapeutic facility and shielding 
design services shall meet the following additional 
requirements: 

( 1 ) The applicant shall submit, for approval 
by the agency, examples of the facility 
and shielding design which will be 
provided to clients. 

(2) The applicant shall submit examples of 
the calculations which will be 
performed as part of the facility and 
shielding design along with any guides, 
occupancy factor rationales, and 
workload estimation rationales which 
will be used. 

(3) The applicant shall ensure that the 
facility and shielding design services 
provided to licensees and registrants of 
the agency satisfy the applicable 
requirements in this Chapter. 

Statutory Authority G.S. 104E-7. 

.0214 TRAINING AND EDUCATIONAL 

REQUIREMENTS FOR EQUIPMENT 
SERVICES 

(a) Each person registered pursuant to Rule 
.0205 of this Section shall be qualified by reason 
of education, training and experience to provide 
the services for which registration is requested. 
The following are minimum qualifications for 
specific types of services: 

( 1 ) Class I - sales of radiation machines 
and machine components to end users: 
The applicant must certify knowledge 
of familiarity with the Ruloa rules and 
Regulation s regulations which govern 
the possession, installation and use of 
radiation machines in North Carolina. 

(2) Class II - installation and service of 
radiation machines and machine 
components including the making of 
diagnostic radiation output 



7:19 



NORTH CAROLINA REGISTER 



January 4, 1993 



2092 



PROPOSED RULES 



measurements to verify performance 
associated with the installation or 
service: 

(A) manufacturer's equipment school for 
service, maintenance and installation 
for the type of machine use (e.g. 
dental intraoral, medical diagnostic or 
medical fluoroscopic) or equivalent 
training; 

(B) training in principles of radiation 
protection; and 

(C) three to six months of experience in 
installation and service of radiation 
machines and machine components. 

(3) Class III - diagnostic radiographic 
facility and shielding design: 

(A) formalized training in principles of 
radiation protection; 

(B) formalized training in shielding 
design; and 

(C) one year of experience in diagnostic 
radiographic facility and shielding 
design for the specific type of 
machine application. 

(4) Class IV - diagnostic fluoroscopic 
facility and shielding design: 

(A) formalized training in principles of 
radiation protection; 

(B) formalized training in shielding 
design; and 

(C) one year of experience in diagnostic 
fluoroscopic facility and shielding 
design for the specific type of 
machine application. 

(5) Class V - diagnostic area radiation 
survey, e.g., shielding evaluation: 

(A) formalized training in basic 
radiological health; 

(B) formalized training in shielding 
evaluation; and 

(C) one year of experience performing 
area radiation surveys. 

(6) Class VI - radiation instrument 
calibration: The applicant must possess 
a current radioactive materials license 
or registration authorizing radiation 
instrument calibration. 

(7) Class VII - therapeutic facility and 
shielding design, area radiation survey, 
or calibration: 

(A) certification by the American Board 
of Radiology in therapeutic 
radiological physics, radiological 
physics, roentgen-ray and gamma ray 
physics, or x-ray and radium physics; 



or certification by the American 
Board of Medical Physics; or 

(B) having the following minimum 
training and experience: 

(i) a master's degree in physics, 
biophysics, radiological physics or 
health physics; 

(ii) one year of full-time training in 
therapeutic radiological physics 

(iii) one year of full-time experience in 
a therapeutic facility including 
personal calibration and 
spot-check of at least one 
machine; 

(C) shall submit a description of the 
procedures that will be utilized in 
performing therapeutic calibrations 
including a list of all guides and 
references to be employed; 

(D) shall submit a copy of all forms, 
reports and documents that will be 
supplied to customers; and 

(E) shall submit one sample of each 
specific type, e.g.. teletherapy, 
accelerator. 

(8) Class VIII - personnel dosimetry 
service: The applicant must hold 
current personnel dosimetry 
accreditation from the National 
Voluntary Laboratory Accreditation 
Program (NVLAP) of the National 
Institute of Standards and Technology 
or use NVLAP accredited dosimetry. 

(9) Class IX - general health physics 
consulting, e.g., independent diagnostic 
radiation output measurements, dose 
analysis, design of safety programs, and 
radiation safety training programs, 
non-healing arts facility and shielding 
design, and area radiation surveys: 

(A) baccalaureate degree in a physical 
science (e.g. physics, chemistry or 
radiologic science), engineering or 
related field and two years of 
progressive experience in medical or 
health physics; graduate training in 
medical or health physics may be 
substituted on a year for year basis; 
or 

(B) certification by the American Board 
of Radiology in therapeutic 
radiological physics, radiological 
physics, roentgen-ray and gamma ray 
physics, or x-ray and radium physics; 
certification by the American Board 



2093 



7:19 



NORTH CAROLINA REGISTER 



January 4, 1993 



aaaoaaaaaanaB 



PROPOSED RULES 



of Health Physics in health physics or 
certification by the American Board 
of Medical Physics. 

(b) Any person not meeting the requirements in 
Paragraph (a) of this Rule may apply to the agency 
for registration, provided such person demonstrates 
education, training and experience which is 
equivalent to that required in Paragraph (a) of this 
Rule. 

(c) Any person registered prior to the effective 
date of this Rule to provide equipment services 
pursuant to Rule .0205 of this Section shall meet 
the education, training and experience 
requirements in Paragraph (a) or (b) of this Rule 
no later than 24 months after the effective date of 
this Rule. 

(d) The agency shall initiate action to terminate 
the registration of any person who fails to comply 
with the requirements of Paragraph (c) of this 
Rule. 

Statuton Authoritx G.S. 104E-7. 



SECTION .0300 - LICENSING OF RADIOACTIVE MATERIAL 

.0303 EXEMPT CONCENTRATIONS: OTHER THAN SOURCE MATERIAL 

(a) No person shall introduce radioactive material into a product or material knowing or having reason to 
believe that it will be transferred to persons exempt under Paragraph (b) of this Rule or equivalent regulations 
of the U.S. Nuclear Regulatory Commission or any agreement state, except in accordance with a specific 
license issued pursuant to Rule .0325 of this Section. 

(b) Except as provided in Paragraph (a) of this Rule, any person is exempt from these Regulations Rules 
to the extent that such person receives, possesses, uses, transfers, owns, or acquires products or materials 
containing radioactive material in concentrations not in excess of those listed in the following table: 

EXEMPT CONCENTRATIONS 

Column II 
Column I Liquid and 

Gas solid 

Element concentration concentration 

(atomic number) Isotope microcurie/ml microcurie/ml 



Antimony (51) SBb 122 3X10" 4 

Sb 124 2X10" 4 

Sb 125 1X10" 3 

Argon (18) Ar 37 1X10 3 

Ar41 4X10' 7 

Arsenic (33) As 73 5X10" 3 

As 74 5X10" 4 

As 76 2X10" 4 

As 77 8X10' 4 

Barium (56) Ba 131 2X10 3 

Ba 140 3X10' 4 



7:79 NORTH CAROLINA REGISTER January 4, 1993 2094 



PROPOSED RULES 



Beryllium (4) 
Bismuth (83) 
Bromine (35) 
Cadmium (48) 



Calcium (20) 

Carbon (6) 
Cerium (58) 



Cesium (55) 



Chlorine (17) 
4X-W- 

Chromium (24) 
Cobalt (27) 



Copper (29) 
Dysprosium (66) 

Erbium (68) 

Europium (63) 



Fluorine (9) 
Gadolinium (64) 

Gallium (31 ) 
Germanium (32) 
Gold (79) 



Hafnium (72) 
Hydrogen ( 1 ) 
Indium f4€H (49) 

Iodine (53) 



Iridium (77) 

Iron (26) 

Krypton (36) 

Lanthanum (57 1 
Lead (82) 



Be 7 


Bi 


206 


Br 


82 


Cd 


109 


Cd 


115m 


Cd 


115 


Ca 


45 


Ca47 


C 


14 


Ce 


141 


Ce 


143 


Ce 


144 


Cs 


131 


Cs 


134m 


Cs 


134 


CI 38 


Cr 


51 


Co 


^ _ 


Co 


58 


Co 


60 


Cu 


64 


Dy 


165 


Dy 


166 


Er 


169 


Er 


171 


Eu 


152 


(¥-2- Tl 2 


Eu 


155 


F 1 


8 


Gd 


153 


Gd 


159 


Ga 72 


Ge 71 


Au 


196 


Au 


198 


Au 


199 


Hf 181 


H . 


3 


In 


113m 


In 


114m 


I 1 


26 


I 1 


31 


I 1 


32 


I 133 


I 134 


Ir 


190 


Ir 


192 


Ir 


194 


Fe 55 


Fe 59 


Kr 


85 m 


Kr 


85 


La 


140 


Pb 203 



4X10" 



X10' 



9X10" 



= 9.2 Hrs.) 



2X10 h 



5X10"' 



3X10-" 

3X10 u 
8X10" 
1X10' 
2X10" 



2X10" 
4X10"' 
3X10-' 
2X10" 
3X10- 1 
3X10' 
9X10- 
5X10' 
8X10" 
9X10' 
4X10"' 
1X10"' 
2X10" 
6X10" 
9X10- 
4X10" 

2X10" 
5X10" 
1X10" 
5X10' 
3X10" 
4X10 3 
4X10" 
9X10"' 
1X10" 
6X10"' 

2X10" 
8X10" 
2X10" 
8X10"' 
4X10' 
2X10" 
2X10" 
5X10"' 
2X10" 
7X10' 
3X10" 
1X10" 
2X10- 
2X10" 
2X10" 
6X10"' 
7X10"' 
1X10" 
2X10" 
4X10' 
3X10"' 
8X10" 
6X10' 
1X10" 
3X10" 
2X10- 
4X10" 



2095 



7:19 



NORTH CAROLIXA REGISTER 



January 4, 1993 



PROPOSED RULES 



Lutetium (71) 


Lu 177 


Manganese (25) 


Mn52 




Mn54 




Mn 56 


Mercury (80) 


Hg 197m 




Hg 197 




Hg 203 


Molybdenum (42) 


Mo 99 


Neodymium (60) 


Nd 147 




Nd 149 


Nickel (28) 


Ni 65 


Niobium 




(Columbium)(41) 


Nb 95 




Nb 97 


Osmium (76) 


Os 185 




Os 191m 




Os 191 




Os 193 


Palladium (46) 


Pd 103 




Pd 109 


Phosphorus (15) 


P 32 


Platinum (78) 


Pt 191 




Pt 193 m 




Pt 197m 




Pt 197 


Polonium (84) 


Po 210 


Potassium (19) 


K42 


Praseodymium (59) 


Pr 142 




Pr 143 


Promethium (61) 


Pm 147 




Pm 149 


Radium (88) 


Ra226 




Ra 228 


Rhenium (75) 


Re 183 




Re 186 




Re 188 


Rhodium (45) 


Rh 103m 




Rh 105 


Rubidium (37) 


Rb 86 


Ruthenium (44) 


Ru 97 




Ru 103 




Ru 105 




Ru 106 


Samarium (62) 


Sm 153 


Scandium (21) 


Sc 46 




Sc 47 




Sc 48 


Selenium (34) 


Se 75 


Silicon (14) 


Si 31 


Silver (47) 


Ag 105 




Ag 1 10m 




Ag 111 


Sodium (11) 


Na 24 


Strontium (38) 


Sr 85 




Sr 89 



1X10- 
3X10" 4 
1X10" 3 
1X10" 3 
2X10' 3 
3X10" 3 
2X10" 4 
2X10- 3 
6X10' 3 
3X10" 4 
1X10" 3 

1X10' 3 
9X10' 3 
7X1 0- 4 
3X10" 2 
2X10" 3 
6X10" 4 
3X10" 3 
9X10" 4 
2X10" 4 
1X10' 3 
1X10" 2 
1X10" 2 
1X10' 3 
7X1 -6 
3X10 3 
3X10" 4 
5X10" 4 
2X10" 3 
4X1 0- 4 
1X10" 7 
3X10' 7 
6X10' 3 
9X10" 4 
6X10 4 
1X10' 1 
1X10° 
7X10" 4 
4X10 3 
8X10' 4 
1X10" 3 
1X10 4 
8X10 4 
4X10" 4 
9X10" 4 
3X10 4 
3X10" 3 
9X10"' 
1X10 3 
3X10" 4 
4X10 4 
2X10-' 
1X10 3 
1X10 4 



7:19 



NORTH CAROLINA REGISTER 



January 4, 1993 



2096 



PROPOSED RULES 



Sulfur (16) 
Tantalum (73) 
Technetium (43) 

Tellurium (52) 



Terbium (65) 
Thallium (81) 



Thulium (69) 
Tin (50) 

Tungsten(Wolfram) (74) 

Vanadium (23) 
Xenon (54) 



Ytterbium (70) 
Yttrium (39) 



Zinc (30) 



Sr 91 

Sr 92 
S 35 
Ta 182 
Tc 96m 
Tc 96 
Te 125m 
Te 127m 
Te 127 
Te 129m 
Te 131m 
Te 132 
Tb 160 
Tl 200 
Tl 201 
Tl 202 
Tl 204 
Tm 170 
Tm 171 
Sn 1 1 3 
Sn 125 
W 181 
W 187 

Y 48 

Xe 131m 
Xe 133 
Xe 135 
Yb 175 

Y 90 

Y 91m 

Y 91 

Y 92 

Y 93 
Zn 65 
Zn 69m 
Zn 69 
Zr 95 
Zr 97 



9X1 0* 



4X1 h 
3X1 0- 6 
1X10* 



7X1 O 4 

7X10" 4 

6X10" 4 

4X1 0- 4 

1X10- 

1X10' 3 

2X10' 3 

6X1 0- 1 

3X10" 3 

3X10" 4 

6X1 0" 1 

3X10 4 

4X10 4 

4X10" 3 

3X10' 

1X10" 3 

1X10 3 

5X10 4 

5X10 1 

9X10" 4 

2X10' 4 

4X10' 3 

7X10" 4 

3X10 4 



1X10'' 
2X10 4 
3X10 : 
3X10 4 
6X10' 4 
3X10" 4 
1X10 3 
7X10 4 
2X10 : 
6X10 4 
2X10' 4 
1X10" 



Zirconium (40) 

Beta and/or gamma emitting 1 X 10 

radioactive material not 
listed above with half-life 
less than 3 years 

(O In Column 1 of the table, in Paragraph (b) of this Rule, values are given only for those materials 
normally used as gases. 

(d) In Column II of the table, in Paragraph (b) of this Rule, the units, microcuries per gram, are used for 
solids. 

(e) Many radioisotopes disintegrate into isotopes which are also radioactive. In expressing the 
concentrations in Paragraph (b) of this Rule, the activity stated is that of the parent isotope and takes into 
account the daughters. 

(f) For purposes of this Rule, where a combination of isotopes is involved, the limit for the combination 
shall be derived as follows: Determine for each isotope in the product the ratio between the concentration 
present in the product and the exempt concentration established in Paragraph (b) of this Rule for the specific 
isotope when not in combination. The sum of the ratios shall not exceed unity. An example of this is: 



W97 



7:19 



NORTH CAROLINA REGISTER 



January 4, 1993 



^--' ■ ***-■-*■>*-*■ 



PROPOSED RULES 



Concentration of Isotope A in Product 

Exempt concentration of Isotope A + 

Concentration of Isotope B in Product 

Exempt concentration of Isotope B less than or equal to 1 

Statutory Authority G.S. 104E-7; 104E-10; 104E-20. 

.0304 EXEMPT QUANTITIES: OTHER THAN SOURCE MATERIAL 

(a) Any person who possesses radioactive material received or acquired under the general license formerly 
provided in Rule .0303(b) of this Section is exempt from the requirements for a license set forth in this Section 
to the extent that such person possesses, uses, transfers or owns such radioactive material. 

(b) This Rule does not authorize the production, packaging or repackaging of radioactive material for 
purposes of commercial distribution, or the incorporation of radioactive material into products intended for 
commercial distribution. 

(c) No person shall, for the purposes of commercial distribution, transfer individual quantities of radioactive 
materials to persons exempt from regulation in Paragraph (a) of this Rule except in accordance with a specific 
license issued by: 

(1) the U.S. Nuclear Regulatory Commission pursuant to Section 32.18 of 10 CFR Part 32 for source 
and byproduct material; 

(2) the agency pursuant to Rule .0326 for radioactive material other than source, byproduct and special 
nuclear material; or 

(3) any agreement state pursuant to equivalent regulation for radioactive material other than source, 
byproduct and special nuclear material. 

(d) Licensees for commercial distribution shall not transfer the quantities of radioactive material to persons 
exempt under Paragraph (e) of this Rule if the licensee knows or has reason to believe that the recipient will 
redistribute the quantities to persons exempt under Paragraph (e) of this Rule. 

(e) Except as provided in Paragraphs (b) and (c) of this Rule, any person is exempt from the rules of this 
Chapter to the extent that such person receives, possesses, uses, transfers, owns or acquires radioactive 
material in individual quantities each of which does not exceed the applicable quantity set forth in the 
following table: 

EXEMPT QUANTITIES 

Radioactive Material Microcuries 

Antimony-122 (Sb 122) 100 

Antimony- 124 (Sb 124) 10 

Antimony-125 (Sb 125) 10 

Arsenic-73 (As 73) 100 

Arsenic-74 (As 74) 10 

Arsenic-76 (As 76) 10 

Arsenic-77 (As 77) 100 

Barium-131 (Ba 131) 10 

Barium- 133 (Ba 133) 10 

Barium- 140 (Ba 140) 10 

Bismuth-210 (Bi 210) 1 

Bromine-82 (Br 82) 10 

Cadmium-109 (Cd 109) 10 

Cadmium- 1 15m (Cd 1 15m) 10 

Cadmium-115 (Cd 115) 100 

Calcium-45 (Ca 45) 10 

Calcium-47 (Ca 47) 10 

Carbon-14 (C 14) 100 

Cerium-141 (Ce 141) 100 

Cerium- 143 (Ce 143) 100 



7:19 NORTH CAROLINA REGISTER January 4, 1993 2098 



PROPOSED RULES 



Cerium- 144 (Ce 144) 
Cesium- 129 (Cs 129) 
Cesium-131 (Cs 131) 
Cesium- 134m (Cs 134m) 
Cesium- 134 (Cs 134) 
Cesium-135 (Cs 135) 
Cesium-136 (Cs 136) 
Cesium-137 (Cs 137) 
Chlorine-36 (CI 36) 
Chlorine-38 (CI 38) 
Chromium-51 (Cr51) 
Cobalt-57 (Co 57) 
Cobalt-58m (Co 58m) 
CobaIt-58 (Co 58) 
Cobalt-60 (Co 60) 
Copper-64 (Cu 64) 
Dysprosium- 165 (Dy 165) 
Dysprosium- 166 (Dy 166) 
Erbium- 169 (Er 169) 
Erbium-171 (Er 171) 
Europium-152 (Eu 152) 9.2h 
Europium- 152 (Eu 152) 13 yr 
Europium- 154 (Eu 154) 
Europium-155 (Eu 155) 
Fluorine-18 (F 18) 
Gadolinium- 153 (Gd 153) 
Gadolinium- 159 (Gd 159) 
Gallium-67 (Ga 67) 
Gallium-72 (Ga 72) 
Germanium-71 (Ge71) 
Gold-198 (Au 198) 
Gold- 199 (Au 199) 
Hafnium- 181 (Hf 181) 
Holmium-166 (Ho 166) 
Hydrogen-3 (H 3) 
Indium-Ill (In 111) 
Indium-1 13m (In 1 13m) 
Indium- 1 14m (In 114m) 
Indium-1 15m(In 1 15m) 
Indium-1 15 (In 115) 
Iodine- 123 (I 123) 
Iodine- 125 (I 125) 
Iodine-126 (I 126) 
Iodine-129 (I 
Iodine-131 (I 
Iodine- 132 (I 
Iodine- 133 (I 
Iodine- 134 (I 
Iodine-135 (I 
I rid in in 
Iridium 



129) 
131) 
132) 
133) 
134) 
135) 
92 (Ir 192) 
94 (Ir 194) 
Iron-52 (Fe 52) 
Iron-55 (Fe 55) 
Iron-59 (Fe 59) 
Krypton-85 (Kr 85) 



100 

,000 

100 

1 

10 

10 

10 

10 

10 

,000 

100 

10 

10 

1 

100 
10 
100 
100 
100 
100 

1 
1 

10 
.000 

10 
100 
100 

10 
100 
100 
100 

10 

100 

.000 

100 

100 

10 
100 

10 
100 

1 
1 

0.1 

1 

10 

1 

10 
10 

10 
100 

10 
100 

10 

100 



2099 



7:19 



XORTH CAROLINA REGISTER 



January 4, 1993 



PROPOSED RULES 



Krypton-87 (Kr 87) 10 

Lanthanum-140 (La 140) 10 

Lutetium-177 (Lu 177) 100 

Manganese-52 (Mn 52) 10 

Manganese-54 (Mn 54) 10 

Manganese-56 (Mn 56) 10 

Mercury- 1 97m (Hg 197m) 100 

Mercury- 197 (Hg 197) 100 

Mercury-203 (Hg 203) 10 

Molybdenum-99 (Mo 99) 100 

Neodymium-147 (Nd 147) 100 

Neodymium-149 (Nd 149) 100 

Nickel-59 (Ni 59) 100 

Nickel-63( Ni 63) 10 

Nickel-65 (Ni 65) 100 

Niobium-93m (Nb 93m) 10 

Niobium-95 (Nb 95) 10 

Niobium-97 (Nb 97) 10 

Osmium- 185 (Os 185) 10 

Osmium-191m (Os 191m) 100 

Osmium-191 (Os 191) 100 

Osmium-193 (Os 193) 100 

Palladium- 103 (Pd 103) 100 

Palladium-109 (Pd 109) 100 

Phosphorus-32 (P 32) 10 

Platinum-191 (Pt 191) 100 

Platinum-193m (Pt 193m) 100 

Platinum- 193 (Pt 193) 100 

Platinum- 197m (Pt 197m) 100 

Platinum- 197 (Pt 197) 100 

Polonium-210 (Po 210) 0.1 

Potassium-42 (K 42) 10 

Potassium-43 (K 43) 10 

Praseodymium- 142 (Pr 142) 100 

Praseodymium- 143 (Pr 143) 100 

Promethium -147 (Pm 147) 10 

Promethium-149 (Pm 149) 10 

Rhenium- 186 (Re 186) 100 

Rhenium-188 (Re 188) 100 

Rhodium- 103m (Rh 103m) 100 

Rhodium- 105 (Rh 105) 100 

Rubidium-81 (Rb 81) 10 

Rubidium-86 (Rb 86) 10 

Rubidium-87 (Rb 87) 10 

Ruthenium-97 (Ru 97) 100 

Ruthenium- 103 (Ru 103) 10 

Ruthenium- 105 (Ru 105) 10 

Ruthenium- 106 (Ru 106) 1 

Samarium-151 (Sm 151) 10 

Samarium-153 (Sm 153) 100 

Scandium-46 (Sc 46) 10 

Scandium-47 (Sc 47) 100 

Scandium-48 (Sc 48) 10 

Selenium-75 (Se 75) 10 

Silicon-31 (Si 31) 100 



7:19 NORTH CAROLINA REGISTER January 4, 1993 2100 



PROPOSED RULES 



Silver- 105 (Ag 105) 
Silver-llOm (Ag 110m) 
Silver-Ill (Ag 111) 
Sodium-22 (Na 22) 
Sodium-24 (Na 24) 
Strontium-85 (Sr 85) 
Strontium-89 (Sr 89) 
Strontium-90 (Sr 90) 
Strontium-91 (Sr 91) 
Strontium-92 (Sr 92) 
Sulphur Sulfur -35 (S 35) 
Tantalum- 182 (Ta 182) 
Technetium-96 (Tc 96) 
Technetium-97m (Tc 97m) 
Technetium-97 (Tc 97) 
Technetium-99m (Tc 99m) 
Technetium-99 (Tc 99) 
Tellurium- 125m (Te 125m) 
Tellurium- 127m (Te 127m) 
Tellurium- 127 (Te 127) 
Tellurium- 129m (Te 129m) 
Tellurium- 129 (Te 129) 
Tellurium-131m (Te 131m) 
Tellurium- 132 (Te 132) 
Terbium- 160 (Tb 160) 
Thallium-200 (Tl 200) 
Thallium-201 (Tl 201) 
Thallium-202 (Tl 202) 
Thallium-204 (Tl 204) 
Thulium- 170 (Tm 170) 
Thulium-171 (Tm 171) 
Tin-113 (Sn 113) 
Tin- 125 (Sn 125) 
Tungsten- 181 (W 181) 
Tungsten- 185 (W 185) 
Tungsten- 187 (W 187) 
Vanadium-48 (V 48) 
Xenon-131m (Xe 131m) 
Xenon- 133 (Xe 133) 
Xenon- 135 (Xe 135) 
Ytterbium- 175 (Yb 175) 
Yttrium-87 (Y 87) 
Yttrium-90 (Y 90) 
Yttrium-91 (Y 91) 
Yttrium-92 (Y 92) 
Yttrium-93 (Y 93) 
Zinc-65 (Zn 65) 
Zinc-69m (Zn 69m) 
Zine-69 (Zn 69) 
Zirconium-93 (Zr 93) 
Zirconium-95 (Zr 95) 
Zirconium-97 (Zr 97) 
Any radioactive material 
not listed above other than 
alpha emitting radioactive 



10 
1 
100 
10 
10 
10 

1 

0.1 

10 

10 
100 

10 

10 
100 
100 
100 

10 

10 

10 
100 

10 
100 

10 

10 

10 
100 
100 
100 

10 

10 

10 

10 

10 

10 

10 
100 

10 

,000 

100 

100 

100 

10 

10 

10 
100 
100 

10 

100 

,000 

10 

10 
10 



2101 



7:19 



NORTH CAROLINA REGISTER 



January 4, 1993 



PROPOSED RULES 



material 
Statutory Authority G.S. 104E-7; W4E-J0(b); 104E-20. 



.0305 EXEMPT ITEM CONTAINING 

OTHER THAN SOURCE MATERIAL 

(a) Authority to transfer possession or control by 
the manufacturer, processor, or producer of any 
equipment, device, commodity, or other product 
containing source, byproduct, or special nuclear 
material whose subsequent possession, use, trans- 
fer, and disposal by all other persons are exempted 
from the rules of this Chapter may be obtained 
only from the U.S. Nuclear Regulatory Commis- 
sion, Washington, D.C. 20555. 

(b) Certain items containing radioactive materi- 
al: 

( 1 ) Except for persons who apply radioac- 
tive material to. or persons who incor- 
porate radioactive material into the 
following products, any person is ex- 
empt from the rules of this Chapter to 
the extent that he receives, possesses, 
uses, transfers, owns, or acquires the 
following products: 
(A) timepieces or hands or dials contain- 
ing not more than the following speci- 
fied quantities of radioactive material 
and not exceeding the following speci- 
fied levels of radiation: 
(i) 25 millicuries of tritium per time- 
piece; 
(ii) five millicuries of tritium per 

hand; 
(iii) 15 millicuries of tritium per dial 
(bezels when used shall be consid- 
ered as part of the dial); 
(iv) 10 microcuries of 
promethium-147 per watch or 200 
microcuries of promethium-147 
per any other timepiece; 
(v) 2 microcuries of 
promethium-147 per watch hand 
or 40 microcuries of 
promethium-147 per other 
timepiece hand; 
(vi) 60 microcuries of 
promethium-147 per watch dial or 
12 microcuries of 
promethium-147 per other 
timepiece dial (bezels when used 
shall be considered as part of the 
dial); 
(vii) the levels of radiation from hands 



0.1 



and dials containing 
promethium-147 will not exceed, 
when measured through 50 
milligrams per square centimeter 
of absorber: 

(I) for wrist watches, 0.1 millirad 
per hour at ten centimeters 
from any surface; 

(II) for pocket watches, 0. 1 
millirad per hour at one 
centimeter from any surface; 

(III) for any other timepiece, 0.2 
millirad per hour at ten 
centimeters from any surface. 

(B) lock illuminators containing not more 
than 15 millicuries of tritium or not 
more than two millicuries of 
promethium-147 installed in 
automobile locks (the levels of 
radiation from each lock illuminator 
containing promethium-147 shall not 
exceed one millirad per hour at one 
centimeter from any surface when 
measured through 50 milligrams per 
square centimeter of absorber); 

(C) balances of precision containing not 
more than one millicurie of tritium 
per balance or not more than 0.5 
millicurie of tritium per balance part; 

(D) automobile shift quadrants containing 
not more than 25 millicuries of 
tritium; 

(E) marine compasses containing not 
more than 750 millicuries of tritium 
gas and other marine navigational 
instruments containing not more than 
250 millicuries of tritium gas: 

(F) thermostat dials and pointers 
containing not more than 25 
millicuries of tritium per thermostat; 

(G) electron tubes, provided that each 
tube does not contain more than one 
of the following specified quantities of 
radioactive material: 

(i) 150 millicuries of tritium per 
microwave receiver protector tube 
or ten millicuries of tritium per 
any other electron tube; 

(ii) one microcurie of cobalt-60; 

(iii) five microcuries of nickel-63; 

(iv) 30 microcuries of krypton-85; 



7:19 



NORTH CAROLINA REGISTER 



January 4, 1993 



2102 



PROPOSED RULES 



(v) five microcuries of cesium- 137; 

(vi) 3 microcuries of 

promethium-147; and provided 

further, that the levels of radiation 

from each electron tube 

containing radioactive material 

does not exceed one millirad per 

hour at one centimeter from any 

surface when measured through 

seven milligrams per square 

centimeter of absorber (for 

purposes of this Subparagraph, 

"electron tubes" include spark gap 

tubes, power tubes, gas tubes 

including glow lamps, receiving 

tubes, microwave tubes, indicator 

tubes, pickup tubes, radiation 

detection tubes and any other 

completely sealed tube that is 

designed to conduct or control 

electrical currents); 

(H) ionizing radiation measuring 

instruments containing for purposes of 

internal calibration or standardization. 

sources of radioactive material each 

not exceeding the applicable quantity 

set forth in Rule .0304(e) of this 

Section. 

(I) spark gap irradiation containing not 

more than one microcurie of cobalt-60 

per spark gap irradiator for use in 

electrically ignited fuel oil burners 

having a firing rate of at least three 

gallons ( 1 1 .4 liters) per hour. 

(2) For purposes of Part (b)(1)(H) of this 

Rule, where there is involved a 

combination of radionuclides, the limit 

for the combination should be derived 

as follows: 

(A) Determine for each radionuclide in an 
ionizing radiation measuring 
instrument the ratio between the 
quantity present in the instrument and 
the exempt quantity established in 
Rule .0304(e) of this Section for the 
specific radionuclide when not in 
combination; 

(B) No ratio shall exceed one and the sum 
of such ratios shall not exceed ten. 

(C) For the purpose of Subparagraph Part 
(b)(1)(H) 0.05 microcurie of 
americium-241 is considered an 
exempt quantity under Rule .0304 of 
this Section. 

(c) Self-luminous products: 



( 1 ) Except for persons who manufacture, 
process, or produce self-luminous 
products containing tritium, krypton-85, 
or promethium-147, any person is 
exempt from the rules of this Chapter 
to the extent that any person receives, 
possesses, uses, transfers, owns, or 
acquires tritium, krypton-85 or 
promethium-147 in self-luminous 
products manufactured. processed, 
produced, imported, or transferred in 
accordance with a specific license 
issued by the U.S. Nuclear Regulatory 
Commission pursuant to Section 32.22 
of 10 CFR Part 32, which license 
authorizes the transfer of the product to 
persons who are exempt from 
regulatory requirements. 

(2) The exemption in Subparagraph (c)(1) 
of this Rule does not apply to tritium. 
krypton-85, or promethium-147 used in 
products for frivolous purposes or in 
toys or adornments. 

(d) Gas and aerosol detectors: 

(1) Except for persons who manufacture, 
process, or produce gas and aerosol 
detectors containing radioactive 
material, any person is exempt from the 
regulations rules of this Chapter to the 
extent that any person receives, 
possesses, uses, transfers, owns or 
acquires radioactive material in gas and 
aerosol detectors designed to protect 
life or property from fires and airborne 
hazards provided that detectors 
containing radioactive material shall be 
manufactured, imported, or transferred 
in accordance with a specific license 
issued by the U.S. Nuclear Regulatory 
Commission or any agreement state, 
pursuant to Section 32.26 of 10 CFR 
32, or equivalent, which authorizes the 
transfer of the detectors to persons who 
are exempt from regulatory 
requirements. 

(2) Gas and aerosol detectors previously 
manufactured and distributed to general 
licensees in accordance with a specific 
license issued by an agreement state 
shall be considered exempt under 
Subparagraph (d)( 1 ) of this Rule, 
provided that the devices are labeled in 
accordance with the specific license 
authorizing distribution of the general 
licensed device, and providing further 



2103 



7:19 



NORTH CAROLINA REGISTER 



January 4, 1993 



PROPOSED RULES 



that the devices meet the requirements 
of Rule .0327. 
(e) Resins containing scandium-46: 

(1) Any person is exempt from these 
Regulation s Rules to the extent that 
such person receives, possesses, uses, 
transfers, owns or acquires synthetic 
plastic resins containing scandium-46 
which are designed for sand 
consolidation in oil wells. These resins 
shall be manufactured or imported in 
accordance with a specific license 
issued by the U.S. Nuclear Regulatory 
Commission, or shall be manufactured 
in accordance with the specifications 
contained in a specific license issued by 
the agency or any agreement state to 
the manufacturer of such resins 
pursuant to licensing requirements 
equivalent to those in Sections 32.16 
and 32.17 of 10 CFR Part 32 of the 
regulations of the U.S. Nuclear 
Regulatory Commission. 

(2) This exemption does not authorize the 
manufacture of any resins containing 
scandium-46. 

Statutory Authority G.S. 104E-7; 1 04E- 10(b); 
104E-20. 

.0318 SPECIFIC LICENSES: GENERAL 

REQUIREMENTS FOR HUMAN USE 

(a) A license application for human use of 
radioactive material will be approved if the agency 
determines that: 

(1) The applicant is qualified by reason of 
training and experience to use the 
material in question for the purpose 
requested in accordance with these 
Regulations Rules; 

(2) The applicant's proposed equipment, 
facilities, and procedures are adequate 
to protect public health from radiation 
hazards and minimize radiological 
danger to life or property; 

(3) The issuance of the license will not be 
inimical to the health and safety of the 
public; 

(4) The following training and supervisory 
relationship are adhered to: 

(A) the user of radioisotopes applied to 
humans for diagnostic, therapeutic, or 
investigational purposes shall be a 
physician authorized by a condition of 
a specific license, including a specific 



license of broad scope. 
(B) No authorized physician may delegate 
to persons who are not physicians 
under the supervision of the 
authorized physician, the following: 
(i) the approval of procedures 
involving the administration to 
patients of radiopharmaceuticals 
or the application to patients of 
radiation from radioisotope 
sources; 
(ii) the prescription of the 
radiopharmaceutical or source of 
radiation and the dose or exposure 
to be administered; 
(iii) the determination of the route of 

administration; 
(iv) the intequretation of the results of 
diagnostic procedures in which 
radiopharmaceuticals are 
administered; 
(5) the applicant satisfies any applicable 
special requirements in Rules .0319 to 
.0322 of this Section. 

(b) Subject to the provisions of Subparagraph 
(a)(4) and Paragraphs (c) to (f) of this Rule, an 
authorized physician may permit technicians and 
other paramedic personnel to perform the 
following activities: 

( 1 ) preparation and quality control testing 
of radiopharmaceuticals and sources of 
radiation; 

(2) measurement of radiopharmaceutical 
doses prior to administration; 

(3) use of appropriate instrumentation for 
the collection of data to be used by the 
physician; 

(4) administration of radiopharmaceuticals 
and radiation from radioisotope sources 
to patients. 

(c) Authorized physicians who permit activities 
to be performed by technicians and other 
paramedical personnel pursuant to Paragraph (b) of 
this Rule shall: 

(1) prior to giving permission, determine 
that the technicians and other 
paramedical personnel have been 
properly trained to perform their duties 
with specific training in the following 
subjects, as applicable to the duties 
assigned: 

(A) general characteristics of radiation 
and radioactive materials; 

( B ) physical, chemical, and 
pharmaceutical characteristics of each 



7:79 



NORTH CAROLINA REGISTER 



January 4, 1993 



2104 



PROPOSED RULES 



radiopharmaceutical to be used; 

(C) mathematics and calculations basic to 
the use and measurement of 
radioactivity, including units of 
radiation dose and radiation exposure; 

(D) use of radiation instrumentation for 
measurements and monitoring 
including operating procedures, 
calibration of instruments, and 
limitations of instruments; 

(E) principles and practices of radiation 
protection; 

(F) additional training in the above 
subjects, as appropriate, when new 
duties are added. 

(2) assure that the technicians and other 
paramedical personnel receive 
appropriate retraining in the subjects 
listed in Subparagraph (c)(1) of this 
Rule to maintain proficiency and to 
keep abreast of developments in the 
field of nuclear medical technology; 

(3) keep records showing the bases for the 
determinations of proper training; and 

(4) retain responsibility as licensee or 
authorized user for the satisfactory 
performance of the activities. 

(d) Certification in nuclear medicine technology 
by the American Registry of Radiologic 
Technologists or in nuclear medical technology by 
the Registry of Medical Technologists of the 
American Society of Clinical Pathologists or the 
Society of Nuclear Medicine will be deemed to 
satisfy the training requirements in Subparagraphs 
(c)(1) and (2) of this Rule. 

(e) An applicant for a license or for amendment 
or renewal of a license shall state whether he 
desires to permit technicians or other paramedical 
personnel to perform activities pursuant to 
Paragraph (b) of this Rule and, if so, shall include 
in his application for license, license amendment, 
or license renewal a statement of the activities to 
be so performed and a description of an adequate 
program for training the personnel, including 
retraining as required to keep abreast of 
developments in technology, or for otherwise 
determining that the personnel are properly trained 
to perform their duties. 

(f) Whenever a technician or other paramedical 
person administers a radiopharmaceutical to a 
patient by injection, a physician shall be 
immediately accessible, but not necessarily a 
physician authorized by the agency to be a user of 
radioisotopes. 



Statutory Authority G.S. 104E-7; 104E-10(b). 

.0321 SPECIFIC LICENSES: GROUPS OF 
DIAGNOSTIC USES 

(a) An application for a specific license pursuant 
to Rule .0318 of this Section for any diagnostic or 
therapeutic use of radioactive material specified in 
groups established in Paragraph (b) of this Rule 
will be approved for all of the diagnostic or 
therapeutic uses within the group which include the 
use specified in the application if: 

( 1 ) the applicant satisfies the requirements 
in Rule .0319 of this Section; 

(2) the applicants proposed radiation 
detection instrumentation is adequate 
for conducting the diagnostic or 
therapeutic procedure specified in the 
appropriate group; 

(3) the physicians designated in the 
application as individual users, have 
adequate clinical experience in the types 
of uses included in the group or groups; 

(4) the physicians and all other personnel 
who will be involved in the preparation 
and use of radioactive material have 
adequate training and experience in the 
handling of radioactive material 
appropriate to their participation in the 
uses included in the group or groups; 

(5) the applicant's radiation safety 
operating procedures are adequate for 
handling and disposal of the radioactive 
material involved in the uses included 
in the group or groups. 

(b) The groups of diagnostic and therapeutic 
radiopharmaceutical uses are established as 
follows: 

( 1 ) Group I includes radiopharmaceuticals 
for which a New Drug application has 
been approved by the U.S. Food and 
Drug Administration for diagnostic 
studies involving measurement of 
uptake, dilution and excretion. This 
group does not include the use of any 
radiopharmaceutical disapproved by the 
North Carolina Radiation Protection 
Commission or involving imaging, 
tumor localization or therapy. 

(2) Croup II includes radiopharmaceuticals 
for which a New Drug application has 
been approved by the U.S. Food and 
Drug Administration for diagnostic 
studies involving imaging and tumor 
localizations. This group does not 
include the use o f a n v 



2105 



7:19 



NORTH CAROLINA REGISTER 



January 4, 1993 



PROPOSED RULES 



radiopharmaceutical disapproved by the 
North Carolina Radiation Protection 
Commission. 

(3) Group III includes the use of generators 
and reagent kits for which a New Drug 
application has been approved by the 
U.S. Food and Drug Administration for 
the preparation of radiopharmaceuticals 
for certain diagnostic uses. This group 
does not include any generator or 
reagent kit disapproved by the North 
Carolina Radiation Protection 
Commission. 

(4) Group IV includes radiopharmaceuticals 
for which a New Drug application has 
been approved by the U.S. Food and 
Drug Administration for therapeutic 
uses which do not normally require 
hospitalization for purposes of radiation 
safety. This group does not include any 
radiopharmaceutical disapproved by the 
North Carolina Radiation Protection 
Commission. 

(c) Any licensee who is authorized to use 
radioactive material in one or more groups 
pursuant to Paragraph (a) of this Rule is subject to 
the following conditions: 

(1) For Groups I, II and IV, no licensee 
shall receive, possess, or use 
radioactive materials except as a 
radiopharmaceutical manufactured in 
the form to be administered to the 
patient, labeled. packaged. and 
distributed in accordance with: 

(A) a specific license issued by the U.S. 
Nuclear Regulatory Commission, 
pursuant to Section 32.72 of 10 CFR 
Part 32; or 

(B) a specific license issued by the agency 
or an agreement state pursuant to 
equivalent regulations. 

(2) For Group III, no licensee shall 
receive, possess, or use generators or 
reagent kits containing radioactive 
material or shall use reagent kits that do 
not contain radioactive material to 
prepare radiopharmaceuticals containing 
radioactive material, except: 

(A) reagent kits. not containing 
radioactive material, that are 
appro ved by the U.S. Nuclear 
Regulatory Commission, the U.S. 
Atomic Energy Commission, or an 
agreement state for use by persons 
licensed for Group III pursuant to 



Paragraph (a) of this Rule or 
equivalent regulations of an agreement 
state or the U.S. Nuclear Regulatory 
Commission; 

(B) generators or reagent kits containing 
radioactive material that are 
manufactured, labeled, packaged, and 
distributed in accordance with a 
specific license issued by the U.S. 
Nuclear Regulatory Commission 
pursuant to Section 32.73 of 10 CFR 
Part 32 or by the agency or an 
agreement state pursuant to equivalent 
regulations; 

(C) any licensee who uses generators or 
reagent kits shall elute the generator 
or process radioactive material with 
the reagent kit in accordance with 
instructions which are approved by 
the L'.S. Nuclear Regulatory 
Commission or an agreement state 
and are furnished by the manufacturer 
on the label attached to or in the 
leaflet or brochure that accompanies 
the generator or reagent kit. 

(3) For Groups I, II and III, any licensee 
using radioactive material for clinical 
procedures other than those specified in 
the product labeling package insert shall 
comply with the product labeling 
regarding: 

(A) chemical and physical form; 

(B) route of administration; and 

(C) dosage range. 

(4) Any licensee who is licensed pursuant 
to Paragraph (a) of this Rule for one or 
more of the medical use groups also is 
authorized to use radioactive material 
under the general license in Rule .0314 
of this Section for the specified IN 
VITRO uses without filing agency form 
as required by Rule .0314(b) of this 
Section, provided that the licensee is 
subject to the other provisions of Rule 
.0314 of this Section. 

(5) Any licensee who is licensed pursuant 
to Paragraph (a) of this Rule for one or 
more of the medical use groups in 
Paragraph (a) of this Rule also is 
authorized, subject to the provisions of 
Subparagraphs Pails (c)(5)(E) and (F) 
of this Rule, to receive, possess, and 
use for calibration and reference 
standards: 

(A) Any radioactive material listed in 



7:19 



NORTH CAROLINA REGISTER 



Januan' 4, 1993 



2106 



PROPOSED RULES 



Group I. Group II. or Group III of 
this Rule with a half-life not longer 
than 100 days, in amounts not to 
exceed 15 millicuries total; 
iB) Any radioactive material listed in 
Group I. Group II. or Group III of 
this Rule with half-life greater than 
100 days in amounts not to exceed 
200 microcuries total; 

(C) Technetium-99m in amounts not to 
exceed 30 millicuries; 

(D) Any radioactive material in amounts 
not to exceed three millicuries per 
source contained in calibration or 
reference sources that have been 
manufactured, labeled, packaged, and 
distributed in accordance with: 

(i) a specific license issued to the 
manufacturer by an agreement 
state pursuant to equivalent state 
regulations: 

(ii) a specific license issued by the 
U.S. Nuclear Regulatory 
Commission pursuant to Section 
32.74 of 10 CFR. Part 32; or 

(iii) an application filed with the U.S. 
Atomic Energy Commission 
pursuant to Section 32.74 of 10 
CFR. part 32: or 

(iv) an application filed with an 
agreement state pursuant to 
equivalent state regulations on or 
before October 15. 1974 for a 
license to manufacture a source 
that the applicant distributed 
commercially on or before August 
16. 1974. on which application 
the U.S. Atomic Energy 
Commission or the U.S. Nuclear 
Regulatory Commission or the 
agreement state has not acted. 

(E) Any licensee who possesses sealed 
sources as calibration or reference 
sources pursuant to Subparagraph 
(c)(5) of this Rule shall cause each 
sealed source containing radioactive 
material other than hydrogen-3 with a 
half-life greater than 30 days in any 
form other than gas to be tested for 
leakage or contamination at intervals 
not to exceed six months. In the 
absence of a certificate from a 
transferor indicating that a test has 
been made within six months prior to 
the transfer, the sealed source shall 



not be used until tested. No leak tests 
are required when: 
(i) The source contains 100 
microcuries or less of beta or 
gamma emitting material or ten 
microcuries or less of alpha 
emitting material, 
(ii) The sealed source is stored and is 
not being used. 
Such source shall be tested for 
leakage prior to any use or transfer 
unless they have been leak tested 
within six months prior to the date of 
use or transfer. 

(F) The leak test shall be capable of 
detecting the presence of 0.005 
microcuries of radioactive material on 
the test sample. The test sample shall 
be taken from the sealed source or 
from the surfaces of the device in 
which the sealed source is 
permanently mounted or stored on 
which contamination might be 
expected to accumulate. Records of 
leak test results shall be kept in units 
of microcuries and maintained for 
inspection by the agency. 

(G) If the leak test reveals the presence of 
0.005 microcuries or more of 
removable contamination, the licensee 
shall immediately withdraw the sealed 
source from use and shall cause it to 
be decontaminated and repaired or to 
be disposed of in accordance with 
agency regulations. A report shall be 
filed within the da\ -- ot the te-t with 
the agency address in Rule .0111 of 
this Chapter describing the equipment 
involved, the test results, and the 
corrective action taken. 

(Hi Any licensee who possesses and uses 

calibration and reference sources 

pursuant to Subparagraph (c)(5) of 

this Rule shall: 

(ij follow the radiation safety and 

handling instructions approved by 

the agency or an agreement state 

and furnished by the manufacturer 

on the label attached to the source 

or permanent container thereof or 

in the leaflet or brochure that 

accompanies the source; 

(ii) maintain such instructions in a 

legible and conveniently available 

form; 



2707 



7:19 



NORTH CAROLINA REGISTER 



January 4, 1993 



PROPOSED RULES 



(iii) conduct a quarterly physical 

inventory to account for all 

sources received and possessed; 

Records of the inventories shall 

be maintained for inspection by 

the agency and shall include the 

quantities and kinds of radioactive 

material, location of sources and 

the date of the inventory. 

(d) Current lists of the radiopharmaceuticals, 

generators, reagent kits, and associated uses in 

Group I to IV are available from the agency at the 

address in Rule .01 1 1 of this Chapter. 

Statutory Authority G.S. 104E-7; 104E- 10(b). 

.0324 SPECIFIC LICENSES: BROAD SCOPE 

(a) In addition to the requirements set forth in 
Rule .0317 of this Section, a specific license of 
broad scope for radioactive material will be issued 
if: 

( 1 ) the applicant has engaged in a 
reasonable number of activities 
involving the use of radioactive 
material; and 

(2) the applicant has established 
administrative controls and provisions 
relating to organization and 
management, procedures, record 
keeping, material control and 
accounting, and management review 
that are necessary to assure safe 
operations, including: 

(A) the establishment of a radiation safety 
committee composed of such persons 
as a radiation safety officer, a 
representative of management, and 
persons trained and experienced in the 
safe use of radioactive material; 

(B) the appointment of a radiation safety 
officer who is qualified by training 
and experience in radiation protection, 
and who is available for advice and 
assistance on radiation safety 
measures; and 

(C) the establishment of appropriate 
administrative procedures to assure: 

(i) control of procurement and use of 
radioactive material; 

(ii) completion of safety evaluations 
of proposed used uses of 
radioactive material which taken 
takes into consideration such 
matters as the adequacy of 
facilities and equipment, training 



and experience of the user, and 
the operating or handling 
procedures; and 
(iii) review, approval, and recording 
by the radiation safety committee 
of safety evaluations of proposed 
uses prepared in accordance with 
Subparagraph Part (a)(2)(C) of 
this Rule prior to use of the 
radioactive material. 

(3) Unless specifically authorized pursuant 
to other Rules rules of this Section, 
persons licensed under this Rule shall 
not: 

(A) conduct tracer studies in the 
environment involving direct release 
of radioactive material; 

(B) receive, acquire, own. possess, use, 
or transfer devices containing 100.000 
curies or more of byproduct material 
in sealed sources used for irradiation 
of materials; 

(C) conduct activities for which a specific 
license issued by the agency under 
.0300 the rules of this Section is 
required; or 

(D) add or cause the addition of 
radioactive material to any food, 
beverage, cosmetic, drug, or other 
product designed for ingestion or 
inhalation by, or application to, a 
human being. 

(4) Each specific license of broad scope 
issued under this Rule shall be subject 
to the condition that radioactive 
material possessed under the license 
may only be used by, or under the 
direct supervision of. individuals 
approved by the licensee's radiation 
safety committee. 

(b) In addition to the requirements set forth in 
Rule .0319 of this Section, a specific license of 
broad scope for radioactive material, human use, 
will be issued only if: 

(1) the applicant has appointed a radiation 
safety committee as required in 
Subparagraph Pa it (a)(2)(A) of this 
Rule, except that this committee shall 
evaluate all proposals for research, 
diagnostic and therapeutic use of 
radioactive material within the medical 
facility; 

(2) membership of the committee consists 
of physicians specializing in nuclear 
medicine, diagnostic radiology, clinical 



7:19 



NORTH CAROLINA REGISTER 



January 4, 1993 



210H 



PROPOSED RULES 



pathology. and a pharmacist 
specializing in radiopharmacy, someone 
competent in radiation safety and a 
representative of the hospital 
management; and 
(3) the applicant for a medical radioactive 
materials license of broad scope has an 
ongoing teaching program with interns 
and residents associated with a 
four-year medical school. 

Statutory Authority G.S. 104E-7; 104E-10(b). 

.0325 SPECIFIC LICENSES: PRODUCTS 
WITH EXEMPT CONCENTRATIONS 

(a) In addition to the requirements set forth in 
Rule .0317 of this Section, a specific license 
authorizing the introduction of radioactive material 
into a product or material owned by or in the 
possession of the licensee or another to be trans- 
ferred to persons exempt under Rule .0303(b) of 
this Section will be issued if: 

(1) the applicant submits a description of 
the product or material into which the 
radioactive material will be introduced, 
intended use of the radioactive material 
and the product or material into which 
it is introduced, method of introduction, 
initial concentration of the radioactive 
material in the product or material, 
control methods to assure that no more 
than the specified concentration is 
introduced into the product or material, 
estimated time interval between intro- 
duction and transfer of the product or 
material, and estimated concentration of 
the radioactive material in the product 
or material at the time of transfer; and 

(2) the applicant provides reasonable assur- 
ance that the product or material is not 
likely to be incorporated in any food, 
beverage, cosmetic, drug or other 
commodity or product designed for 
ingestion or inhalation by. or applica- 
tion to, a human being, use of lower 
concentration is not feasible and that 
the concentrations of radioactive materi- 
al at the time of transfer, or that recon- 
centration of the radioactive material, 
will not exceed the concentrations listed 
in the table in Rule .0303(b) of this 
Section. 

(A) Many radioisotopes disintegrate into 
isotopes which are also radioactive. 
In expressing the concentrations in the 



table in Rule .0303(b) of this Section, 
the activity stated is that of the parent 
isotope and takes into account the 
daughters. 

(B) Values are given in Column I of the 
table in Rule .0303(b) of this Section, 
only for those materials normally used 
as gases. 

(C) For purposes of this Rule where there 
is involved a combination of isotopes, 
the limit for the combination shall be 
derived as follows: 

(i) Determine for each isotope in the 
product the ratio between the 
concentration present in the prod- 
uct and the exempt concentration 
established in the table in Rule 
.0303(b) of this Section for the 
specific isotope when not in com- 
bination. 

(ii) The sum of these ratios shall not 
exceed unity. 
Example: 

Concentration of Isotope A m Product 
Exempt concentration of Isotope A + 

Concentration of Isotope B in Product 

Exempt concentration of Isotope B less than 

or equal to 1 

(b) Each person licensed under Paragraph (a) of 
this Rule shall file with the agency an annual 
report which shall identify': 

( 1 ) the type and quantity of each product or 
material into which radioactive material 
has been introduced during the report- 
ing period; 

(2) name and address of the person who 
owned or possessed the product or 
material, into which radioactive materi- 
al has been introduced, at the time of 
introduction: 

(3) the type and quantity of radionuclide 
introduced into each such product or 
material: and 

(4) the initial concentrations of the 
radionuclide in the product or material 
at time of transfer of the radioactive 
material by the licensee. 

If no transfers of radioactive material have been 
made pursuant to Paragraph (a) of this Rule during 
the reporting period, the report shall so indicate. 
The report shall cover the 12-month period ending 
June 30, and shall be filed within 30 days thereaf- 



2109 



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January 4, 1993 



PROPOSED RULES 



ter. 



Statutory Authority G.S. 104E-7; 104E-W(b). 

.0326 SPECIFIC LICENSES: EXEMPT 
DISTRIBUTION 

(a) An application for a specific license to 
distribute radioactive material other than source, 
byproduct or special nuclear material to persons 
exempt from these Regulations Rules pursuant to 
Rule .0304(e) of this Section will be approved if: 

( 1 ) The radioactive material is not con- 
tained in any food, beverage, cosmetic. 
drug, or other commodity designed for 
ingestion or inhalation by, or applica- 
tion to. a human being; 

(2) The radioactive material is in the form 
of processed chemical elements, com- 
pounds, or mixtures, tissue samples, 
bioassay samples, counting standards, 
plated or encapsulated sources, or 
similar substances, identified as radio- 
active and to be used for its radioactive 
properties, but is not incorporated into 
any manufactured or assembled com- 
modity, product, or device intended for 
commercial distribution: and 

(3) The applicant submits copies of proto- 
type labels and brochures and the agen- 
cy approves their labels and brochures. 

(b) The license issued pursuant to this Rule is 
subject to the following conditions: 

( 1 ) No more than ten exempt quantities 
shall be sold or transferred in any 
single transaction. An exempt quantity 
may be composed of fractional parts of 
one or more of the exempt quantity 
provided the sum of the fraction shall 
not exceed unity. 

(2) Each exempt quantity shall be separate- 
ly and individually packaged. No more 
than ten packaged exempt quantities 
shall be contained in any outer package 
for transfer to persons exempt pursuant 
to Rule .0304(e) of this Section. The 
outer package shall be such that the 
dose rate at the external surface of the 
package does not exceed 0.5 millirem 
per hour. 

(3) The immediate container of each quan- 
tity of separately packaged fractional 
quantity of radioactive material shall 
bear the words "Radioactive Material". 

(4) In addition to the labeling information 
required by Subparagraph (b)(3) of this 



Rule, the label affixed to the immediate 
container, or an accompanying bro- 
chure, shall: 

(A) state that the contents are exempt 
from U.S. Nuclear Regulatory Com- 
mission or agreement state require- 
ments; 

(B) contain the following statements: 
(i) Radioactive material; 

(ii) Not for human use; 

(iii) Introduction into foods, beverag- 
es, cosmetics, drugs. or 
medicinals. or into products 
manufactured for commercial 
distribution is prohibited: 

(iv) Exempt quantities should not be 
combined. 

(C) set forth appropriate additional 
radiation safety precautions and 
instructions relating to the handling, 
use, storage, and disposal of the 
radioactive material. 

(c) Each person licensed under Paragraph (a) of 
this Rule shall maintain records identifying, by 
name and address, each person to whom 
radioactive material is transferred for use under 
Rule .0304(e) of this Section or the equivalent 
regulations of an agreement state, and stating the 
kinds and quantities of radioactive material 
transferred. An annual summary report stating the 
total quantity of each radionuclide transferred 
under the specific license shall be filed with the 
agency. Each report shall cover the 12 month 
period ending June 30, and shall be filed within 30 
days thereafter. If no transfers of radioactive 
material have been made pursuant to this Rule 
during the reporting period, the report shall so 
indicate. 

(d) Authority to transfer possession or control 
by the manufacturer, processor, or producer of any 
equipment, device, commodity, or other product 
containing source or byproduct material whose 
subsequent possession, use. transfer, and disposal 
by all other persons are exempted from regulatory 
requirements may be obtained only from the U.S. 
Nuclear Regulatory Commission, Washington, 
D.C. 20555. 

Statutory Authority G.S. 104E-7; 104E-10(b). 

.0336 COPIES OF APPLICABLE FEDERAL 
REGULATIONS 

Copies of the applicable regulation from Title 10 
of the Code of Federal Regulation s (10 CFR) 
referenced in Rule s .0321, .0327, .0329, .0330. 



7:19 



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2110 



PROPOSED RULES 



.0332. .0333. .033 4 , .0335, .0336. and .0337 of 
this Section are available ; from the agency at the 
address in Rule .01 1 1 of thia Chapter. 

Statutory Authority G.S. 104E-7; W4E-10(b). 

.0337 ISSUANCE OF SPECIFIC LICENSES 

(a) Upon a determination that an application 
meets the requirements of the Act and the 
Regulations rules of this Section, the agency will 
issue a specific license authorizing the proposed 
activity in such form and containing such 
conditions and limitations as it deems appropriate 
or necessary. 

(b) The agency may incorporate in any license 
at the time of issuance, or thereafter by 
amendment, such additional requirements and 
conditions with respect to the licensee's receipt, 
possession, use and transfer of radioactive material 
subject to this Chapter as it deems appropriate or 
necessary in order to: 

( 1 ) minimize danger to public health and 

safety or property; 

(2) require such reports and the keeping of 
such records, and provide for such 
inspections of activities under the 
license as may be appropriate or 
necessary; and 

(3) prevent loss or theft of radioactive 
material subject to this Section. 

Statutory Authority G.S. 104E-7; 104E-10(b). 

.0338 SPECIFIC TERMS AND CONDITIONS 
OF LICENSES 

(a) Each license issued pursuant to thi s part the 
rules [n this Section shall be subject to all the 
provisions of the Act, now or hereafter in effect, 
to all rules and regulations adopted pursuant to 
provisions of the Act and to orders of the agency. 

(b) No license issued or granted pursuant to this 
Section and no right to possess or utilize 
radioactive material granted by any license issued 
pursuant to this Section shall be transferred, 
assigned, or in any manner disposed of, either 
voluntarily or involuntarily, directly or indirectly, 
through transfer of control of any license to any 
person unless the agency, after securing full 
information, finds that the transfer is in accordance 
with the provisions of the Act, and gives its 
consent in writing. 

(c) Each person licensed by the agency pursuant 
to this Section shall confine his use and possession 
of the radioactive material licensed to the locations 
and purposes authorized in the license. 



(d) Each licensee shall notify the agency in 
writing immediately following the filing of a 
voluntary' or involuntary petition for bankruptcy 
under any Chapter of Title 1 1 (Bankruptcy) of the 
United States Code by or against: 

(1) licensee; 

(2) an entity [as that term is defined in 1 1 
U.S.C. 101(14)] controlling the licensee 
or listing the license or licensee as 
property of the estate; or 

(3) an affiliate [as that term is defined in 1 1 
U.S. C. U.S.C. 101(2)] of the licensee. 

(e) The notification in Paragraph (d) of this Rule 
shall indicate: 

(1) the bankruptcy court in which the 
petition for bankruptcy was filed; and 

(2) the date of the filing of the petition. 

(f) Licensees required to submit emergency 
plans pursuant to Rule .0352 of this Section shall 
follow the emergency plan approved by the 
agency. The licensees may change the approved 
plan without agency approval only if the licensee 
believes the changes do not decrease the 
effectiveness of the plan and are submitted to the 
agency no later than 20 calendar days after the 
changes are made. The licensee shall furnish the 
change to affected off-site response organizations 
within six months after the change is made. 
Proposed changes that the licensee believes are 
likely to decrease, or may potentially decrease, the 
effectiveness of the approved emergency plan shall 
not be implemented without prior application to 
and prior approval by the agency. 

Statutory Authority G.S. I04E-7; 104E-I0(b). 

.0343 TRANSFER OF MATERIAL 

(a) No licensee shall transfer radioactive 
material except as authorized pursuant to this 
Section. 

(b) Except as otherwise provided in his license 
and subject to the provisions of Paragraphs (c), (d) 
and (e) of this Rule any licensee may transfer 
radioactive material to: 

( 1 ) the agency; 

(2) the U.S. Department of Energy; 

(3) any person exempt from the 
Regulations rules in this Section to the 
extent permitted under the exemption; 

(4) any person authorized to receive the 
radioactive material under terms of a 
general license or its equivalent, or a 
specific license or equivalent licensing 
document, issued by the agency, the 
U.S. Nuclear Regulatory Commission. 



2111 



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January 4, 1993 



PROPOSED RULES 



or an agreement state, or any person 
otherwise authorized to receive the 
radioactive material by the federal 
government or any agency thereof, the 
agency, or an agreement state; or 
(5) as otherwise authorized by the agency 
in writing. 

(c) A licensee may transfer material to the 
agency only after receiving prior approval from 
the agency. 

(d) Before transferring radioactive material to a 
specific licensee of the agency, the U.S. Nuclear 
Regulatory Commission, or an agreement state, or 
to a general licensee who is required to register 
with the agency, the U.S. Nuclear Regulatory 
Commission, or an agreement state prior to receipt 
of the radioactive material, the licensee 
transferring the material shall verify that the 
transferee's license authorizes the receipt of the 
type, form, and quantity of radioactive material to 
be transferred. 

(e)The following methods for the verification 
required by Paragraph (d) of this Rule are 
acceptable: 

( 1 ) The transferor may have in his 
possession, and read, a current copy of 
the transferree's specific license or 
registration certificate; 

(2) The transferor may have in his 
possession a written certificate by the 
transferee that he is authorized by 
license or registration certificate to 
receive the type. form, and quantity of 
radioactive material to be transferred, 
specifying the license or registration 
certificate number, issuing agency, and 
expiration date; 

(3) For emergency shipments the transferor 
may accept oral certification by the 
transferee that he is authorized by 
license or registration certificate to 
receive the type, form, and quantity of 
radioactive material to be transferred, 
specifying the license or registration 
certificate number, issuing agency, and 
expiration date; provided the oral 
certification is confirmed in writing 
within ten days after the date of the oral 
certification; 

(4) The transferor may obtain other sources 
of information compiled by a reporting 
service from official records of the 
agency, the U.S. Nuclear Regulatory 
Commission, or the licensing agency of 
an agreement state as to the identity of 



licensees and the scope and expiration 

dates of licenses and registration; or 

(5) When none of the methods of 

verification described in this Rule are 

readily available or when a transferor 

desires to verify that information 

received by one of the methods is 

correct or updated, the transferor may 

obtain and record confirmation from the 

agency, the U.S. Nuclear Regulatory 

Commission, or the licensing agency of 

an agreement state that the transferee is 

licensed to receive the radioactive 

material. 

(f) Preparation for shipment and transport of 

radioactive material shall be in accordance with the 

provisions of Rule .0346 of this Section. 

Statutory Authority G.S. 104E-7; 104E-10(b). 

.0344 MODIFICATION: REVOCATION: 

AND TERMINATION OF LICENSES 

(a) The terms and conditions of all licenses are 
subject to amendment, revision or modification and 
all licenses are subject to suspension or revocation 
by reason of: 

( 1 ) amendments to the Act, 

(2) rules and regulations adopted pursuant 
to provisions of the Act, or 

(3) orders issued by the agency pursuant to 
provisions of the Act and rules and 
regulations adopted pursuant to 
provisions of the Act. 

(b) Any license may be revoked, suspended, or 
modified, in whole or in part: 

( 1 ) for any material false statement in the 
application or in any statement of fact 
required by provisions of this Section; 

(2) because of conditions revealed by: 

(A) the application; 

(B) any statement of fact; 

(C) any report, record, inspection or other 
means, which would warrant the 
agency to refuse to grant a license or 
an original application; or 

(3) for violation of, or failure to observe 
any of the terms and conditions of the 
Act. the license, the Rules rules of this 
Chapter, or order of the agency. 

(c) Except in cases of willfulness or those in 
which the public health, interest or safety requires 
otherwise, prior to the institution of proceedings 
for modification, revocation, or suspension of a 
license, the agency shall: 

( 1 ) call to the attention of the licensee in 



7:19 



NORTH CAROLINA REGISTER 



January 4, 1993 



2112 



PROPOSED RULES 



writing the facts or conduct which may 
warrant these actions, and 
(2) provide an opportunity for the licensee 
to demonstrate or achieve compliance 
with all lawful requirements. 
(d) The agency may terminate a specific license 
upon request submitted by the licensee to the 
agency in writing. 

Statutory Authority G.S. 104E-7; 104E-10(b). 

.0345 RECIPROCAL RECOGNITION OF 
LICENSES 

(a) Subject to these Regulations Rules , any 
person who holds a specific license from the U.S. 
Nuclear Regulator},' Commission or an agreement 
state, and issued by the agency having jurisdiction 
where the licensee maintains an office for directing 
the licensed activity and at which radiation safety 
records are normally maintained, is hereby granted 
a general license to conduct the activities 
authorized in such licensing document within this 
state for a period not in excess of 180 days in any 
calendar year provided that the following 
requirements are satisfied: 

(1) The licensing document does not limit 
the activity authorized by such 
document to specified installations or 
locations: 

(2) The out-of-state licensee notifies the 
agency in writing at least three days 
prior to engaging in such activity; such 
notification shall indicate the location, 
period, and type of proposed possession 
and use within the state, and shall be 
accompanied by a copy of the pertinent 
licensing document; if. for a specific 
case, the three day period would 
impose an undue hardship on the 
out-of-state licensee, he may upon 
application to the agency, obtain 
permission to proceed sooner: the 
agency may waive the requirement for 
filing additional written notifications 
during the remainder of the calendar 
year following the receipt of the initial 
notification from a person engaging in 
activities under the general license 
provided in this Rule; 

(3) The out-of-state licensee complies with 
all applicable regulations of the agency 
and with all the terms and conditions of 
his licensing document, except any such 
terms and conditions which may be 
inconsistent with applicable regulations 



of the agency; 

(4) The out-of-state licensee supplies such 
other information as the agency may 
request; and 

(5) The out-of-state licensee shall not 
transfer or dispose of radioactive 
material possessed or used under the 
general license provided in this Rule 
except by transfer to a person: 

(A) specifically licensed by the agency or 
by the U.S. Nuclear Regulatory 
Commission to receive the material. 

01 

(B) exempt from the requirements for a 
license for the material under Rule 
.0303 of this Section. 

(b) Additional reciprocity is provided in Rule 
.0310 of this Section. 

(c) The agency may withdraw, limit, or qualify 
its acceptance of any specific license or equivalent 
licensing document issued by another agency, or 
any product distributed pursuant to such licensing 
document, upon determining that the action is 
necessary in order to prevent undue hazard to 
public health and safety or property. 

Statutory Authority G.S. I04E-7; 104E- 10(b). 

.0346 PREPARATION OF RADIOACTIVE 
MATERIAL FOR TRANSPORT 

(a) No licensee shall deliver any radioactive 
material to a carrier for transport, unless: 

(1) The licensee complies with the 
applicable requirements of the 
regulations, appropriate to the mode of 
transport, of the U.S. Department of 
Transportation insofar as such 
regulations relate to the packing of 
radioactive material. and to the 
monitoring, marking and labeling of 
those packages: 

(2) The licensee has established procedures 
for opening and closing packages in 
which radioactive material is 
transported to provide safety and to 
assure that, prior to the delivery to a 
carrier for transport, each package is 
properly closed for transport; and 

(3) Prior to delivery of a package to a 
carrier for transport, the licensee shall 
assure that any special instructions 
needed to safely open the package are 
sent to, or have been available to the 
consignee. 

(b) For the purpose of this Rule, a licensee who 



2113 



7:19 



XORTH CAROLIXA REGISTER 



January 4, 1993 



PROPOSED RULES 



transports his own licensed material as a private 
carrier is considered to have delivered the material 
to a carrier for transport. 

(c) In addition to the requirements of Paragraphs 
(a) and (b) of this Rule, prior to the transport of 
any nuclear waste, as defined in Part (d)(2)(A) of 
Rule .0316 (d)(2)(A) of this Section, outside the 
confines of the licensee's facility or other place of 
use or storage, or prior to the delivery of any 
nuclear waste to a carrier for transport, each 
licensee shall provide advance notification of such 
transport to the governor's designee of each state 
through which the waste will be transported. 

(d) Each advance notification required by 
Paragraph (c) of this Rule shall contain the 
following information: 

(1) the name, address, and telephone 
number of the shipper, carrier and 
receiver of the shipment; 

(2) a description of the nuclear waste 
contained in the shipment as required 
by the regulations of the U.S. 
Department of Transportation in 49 
CFR 172.202 and 172.203(d): 

(3) the point of origin of the shipment and 
the seven-day period during which 
departure of the shipment is estimated 
to occur; 

(4) the seven-day period during which 
arrival of the shipment at state 
boundaries is estimated to occur; 

(5) the destination of the shipment, and the 
seven-day period during which arrival 
of the shipment is estimated to occur; 
and 

(6) a point of contact with a telephone 
number for current shipment 
information. 

(e) The notification required by Paragraph (c) of 
this Rule shall be made in writing to the office of 
each appropriate governor or governor's designee. 
A notification delivered by mail must be 
postmarked at least seven days before the 
beginning of the seven-day period during which 
departure of the shipment is estimated to occur. A 
notification delivered by messenger must reach the 
office of the governor or governor's designee at 
least four days before the beginning of the 
seven-day period during which departure of the 
shipment is estimated to occur. A copy of the 
notification shall be retained by the licensee for 
one year. 

(f) The licensee shall notify each appropriate 
governor or governor's designee of any changes to 
schedule information provided pursuant to 



Paragraph (c) of this Rule. Such notification shall 
be by telephone to a responsible individual in the 
office of the governor or governor's designee of 
the appropriate state or states. The licensee shall 
maintain for one year a record of the name of the 
individual contacted. 

(g) Each licensee who cancels a nuclear waste 
shipment for which advance notification has been 
sent shall send a cancellation notice to the 
governor or governor's designee of the appropriate 
state or states. A copy of the notice shall be 
retained by the licensee for one year. 

(h) A list of governors or governors' designees 
for other states is available from the agency by 
contacting the North Carolina Division of 
Radiation Protection. P.O. Box 27687, Raleigh. 
North Carolina 27611-7687, Phone No. 
919/ 733 4 283 571-4141 or facsimile number 
919/571-4148 . For the notification required in 
Paragraphs (c) through (g) of this Rule in North 
Carolina: 

(1) governor's designee is the North 
Carolina Highway Patrol. Operations 
Office; 

(2) mailing address: P. O. Box 27687, 
Raleigh. North Carolina 2761 1-7687; 

(3) telephone 919/733-4030 from 8 a.m. to 
5 p.m. workdays, and 919/733-3861 all 
other times. 



Statutory Authority G.S. 
104E-15(a). 



104E-7; 104E-10(h); 



7:19 



NORTH CAROLINA REGISTER 



January 4, 1993 



2114 



PROPOSED RULES 



.0352 EMERGENCY PLANS 

(a) Each application to possess radioactive materials in unsealed form, on foils or plated sources, or sealed 
in glass in excess of the quantities in the table in Subparagraph (e)(1) of this Rule must contain either: 

( 1 ) an evaluation showing that the maximum dose to a person off-site due to a release of radioactive 
materials would not exceed one rem effective dose equivalent or five rems to the thyroid; or 

(2) an emergency plan for responding to a release of radioactive material. 

(b) One or more of the following factors may be used to support an evaluation submitted under 
Subparagraph (a)(1) of this Rule: 

(1) the radioactive material is physically separated so that only a portion could be involved in an 
accident; 

(2) all or part of the radioactive material is not subject to release during an accident because of the way 
it is stored or packaged; 

(3) the release fraction in the respirable size range would be lower than the release fraction shown in 
Subparagraph (e)(1) of this Rule due to the chemical or physical form of the material; 

(4) the solubility of the radioactive material would reduce the dose received; 

(5) facility design or engineered safety features in the facility would cause the release fraction to be 
lower than shown in Subparagraph (e)(1) of this Rule; 

(6) operating restrictions or procedures would prevent a release fraction as large as that shown in 
Subparagraph (e)(1) of this Rule; or 

(7) other factors appropriate for the specific facility. 

(c) An emergency plan for responding to a release of radioactive material submitted under Subparagraph 
(a)(2) of this Rule must include the following information: 

(1) brief description of the licensee's facility and area near the site; 

(2) identification of each type of radioactive materials accident for which protective actions may be 
needed; 

(3) classification system for classifying accidents as alerts or site area emergencies; 

(4) identification of the means of detecting each type of accident in a timely manner; 

(5) brief description of the means and equipment for mitigating the consequences of each type of 
accident, including those provided to protect workers on-site, and a description of the program for 
maintaining the equipment; 

(6) brief description of the methods and equipment to assess releases of radioactive materials; 

(7) brief description of the responsibilities of licensee personnel, should an accident occur, including 
identification of personnel responsible for promptly notifying off-site response organizations and 
the agency, and responsibilities for developing, maintaining, and updating the plan: 

(8) brief description of notification and coordination, to include a commitment to and a brief 
description of the means to promptly notify off-site response organizations and request off-site 
assistance, including medical assistance for the treatment of contaminated injured on-site workers 
when appropriate, provided that: 

(A) a control point shall be established; 

(B) the notification and coordination shall be planned so that unavailability of some personnel, parts 
of the facility, and some equipment will not prevent the notification and coordination; 

(C) the licensee shall also commit to notify the agency immediately after notification of the 
appropriate off-site response organizations, not to exceed one hour after the licensee declares an 
emergency; and 

(D) the reporting requirements in Subparagraph (c)(8) of this Rule do not substitute for or relieve the 
licensee from responsibility for complying with the requirements in the Emergency Planning and 
Community Right-to-Know Act of 1986. Title III. Public Law 99-499 or other state or federal 
reporting requirements; 

(9) brief description of the types of information on facility status, radioactive releases, and 
recommended protective actions, if necessary, to be given to off-site response organizations and 
to the agency: 

(10) brief description of the frequency, performance objectives and plans for the training that the 
licensee will provide workers on how to respond to an emergency, including any special 
instructions and orientation tours the licensee would offer to fire, police, medical and other 
emergency personnel, where such training shall: 



2115 7:19 NORTH CAROLINA REGISTER Januan' 4, 1993 



PROPOSED RULES 



(A) familiarize personnel with site-specific emergency procedures; and 

(B) thoroughly prepare site personnel for their responsibilities in the event of accident scenarios 
postulated as most probable for the specific site, including the use of team training for such 
scenarios; 

(11) brief description of the means of restoring the facility to a safe condition after an accident; 

(12) brief description of provisions for conducting quarterly communications checks with off-site 
response organizations and biennial on-site exercises to test response to simulated emergencies 
where such provisions shall meet the following specific requirements; 

(A) quarterly communications checks with off-site response organizations shall include the check and 
update of all necessary telephone numbers; 

(B) while participation of off-site response organizations in biennial exercises is encouraged but not 
required, the licensee shall invite off-site response organizations to participate in the biennial 
exercises; 

(C) accident scenarios for biennial exercises shall not be known to most exercise participants; 

(D) the licensee shall critique each exercise using individuals who do not have direct implementation 
responsibility for the plan; and 

(E) critiques of exercises shall evaluate the appropriateness of the plan, emergency procedures, 
facilities, equipment, training of personnel, and overall effectiveness of the response; and 

(F) deficiencies found by the critiques in Subparagraph Part (c)( 12)(E) of this Rule shall be corrected; 

(13) certification that the applicant has met its responsibilities under the Emergency Planning and 
Community Right-to-Know Act of 1986, Title III. Public Law 99-499, if applicable to the 
applicant's activities at the proposed place of use of the radioactive material. 

(d) The licensee shall allow the off-site response organizations expected to respond in case of an accident 
60 days to comment on the licensee's emergency plan before submitting it to the agency. The licensee shall 
provide any comments received within the 60 day comment period to the agency with the emergency plan. 

(e) Quantities of radioactive material requiring consideration of the need for an emergency plan for 
responding to a release as used in this Rule and special instructions for use are: 

(1) TABLE 



RADIOACTIVE MATERIAL 



RELEASE 
FRACTION 



QUANTITY 
(CURIES) 



Actinium-228 

Americium-241 

Americium-242 

Americium-243 

Antimony- 124 

Antimony- 126 

Barium- 133 

Barium- 140 

Bismuth-207 

Bismuth-210 

Cadmium- 109 

Cadmium- 1 13 

Calcium-45 

Californium-252 

Carbon- 14 (NON CO) 

Cerium-141 

Cerium- 144 

Cesium- 134 

Cesium- 137 

Chlorine-36 

Chromium-51 

Cobalt-60 

Copper-64 



0.001 
.001 
.001 
.001 
.01 
.01 

.()] 

.01 
.01 

.01 
01 
.01 
.01 
.001 
.01 
.01 
.01 
.01 
.01 
.5 
.01 
.001 
.01 



4,000 

2 

2 

2 

4,000 

6,000 

10,000 

30,000 

5,000 

600 

1.000 

80 

20.000 

9 (20 mg) 

50,000 

10,000 

300 

2,000 

3,000 

100 

300,000 

5. OCX) 

200,000 



7:19 



NORTH CAROLINA REGISTER 



January 4, 1993 



2116 



PROPOSED RULES 



Curium-242 

Curium-243 

Curium-244 

Curium-245 

Europium- 152 

Europium- 154 

Europium- 155 

Germanium-68 

Gadolinium- 153 

Gold-198 

Hafnium- 172 

Hafnium-181 

Holmium-166 m 

Hydrogen-3 

lodine-125 

Iodine-131 

Indium- 1 14 m 

Iridium- 192 

Iron-55 

Iron-59 

Krypton-85 

Lead-210 

Manganese-56 

Mercury-203 

Molybdenum-99 

Neptunium-237 

Nickel-63 

Niobium-94 

Phosphorus-32 

Phosphorus-33 

Polonium-210 

Potassium-42 

Promethium-145 

Promethium-147 

Ruthenium- 106 

Samarium-151 

Scandium-46 

Selenium-75 

Silver- 110 m 

Sodium-22 

Sodium-24 

Strontium-89 

Strontium-90 

Sulfur-35 

Technetium-99 

Technetium-99 m 

Tellurium-127 m 

Tellurium- 129 m 

Terbium- 160 

Thulium- 170 

Tin-113 

Tin- 123 

Tin-126 

Titanium-44 

Vanadium-48 



.001 

.001 

.001 

.001 

.01 

.01 

.01 

.01 

.01 

.01 

.01 

.01 

.01 

.5 

.5 

.5 

.01 

.001 

.01 

.01 
1.0 

.01 

.01 

.01 

.01 

.001 

.01 

.01 

.5 

.5 

.01 

.01 

.01 

.01 

.01 

.01 

.01 

.01 

.01 

.01 

.01 

.01 

.01 

.5 

.01 

.01 

.01 

.01 

.01 

.01 

.01 

.01 

.01 

.01 

.01 



60 

3 

4 

2 

500 

400 

3,000 

2,000 

5,000 

30.000 

400 

7,000 

100 

20,000 

10 

10 

1.000 

40,000 

40.000 

7.000 

6,000.000 

8 

60.000 

10,000 

30.000 

2 

20.000 

300 

100 

1.000 

10 

9.000 

4.000 

4.000 

200 

4,000 

3.000 

10.000 

1.000 

9.000 

10.000 

3.000 

90 

900 

10.000 

400.000 

5.000 

5.000 

4.000 

4.000 

10.000 

3.000 

1.000 

100 

7.000 



2117 



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NORTH CAROLINA REGISTER 



Januan 4, 1993 



PROPOSED RULES 



Xenon- 133 

Yttrium-91 

Zinc-65 

Zirconium-93 

Zirconium-95 

Any other beta-gamma emitter 

Mixed fission products 

Mixed corrosion products 

Contaminated equipment beta-gamma 

Irradiated materia], any form 

other than solid noncombustible 

Irradiated material, solid 

noncombustible 

Mixed radioactive waste 

beta-gamma 

Packaged mixed waste, beta-gamma 

Any other alpha emitter 

Contaminated equipment, alpha 

Packaged waste, alpha 



1.0 

.01 
.01 
.01 
.01 
.01 
.01 
.01 
.001 

.01 

.001 

.01 

.001 

.001 

.0001 

.0001 



900,000 

2,000 

5,000 

400 

5,000 

10,000 

1,000 

10,000 

10,000 

1,000 

10.000 

1,000 
10,000 

2 
20 

20 



(2) For combinations of radioactive materials, consideration of the need for an emergency plan is 
required if the sum of the ratios of the quantity of each radioactive material authorized to the 
quantity listed for that material in the table in Subparagraph (e)(1) of this Rule exceeds one. 

(3) Waste packaged in Type B containers, as defined in 10 CFR Part 71.4. does not require an 
emergency plan. 



Statutory Authority G.S. 104E-7; 104E-18. 

SECTION .0500 - SAFETY 

REQUIREMENTS FOR INDUSTRIAL 

RADIOGRAPHY OPERATIONS 

.0501 PURPOSE AND SCOPE 

(a) The regulations rules in this Section establish 
radiation safety requirements for persons utilizing 
sources of radiation for industrial radiography. 
The requirements of this Section are in addition to 
and not in substitution for the other requirements 
of this Chapter. 

(b) The regulations rules in this Section apply to 
all licensees or registrants who use sources of 
radiation for industrial radiography; provided, 
however that nothing in this Section shall apply to 
the use of sources of radiation in the healing arts. 

Statutory- Authority G.S. 104E-7. 

.0507 LEAK TESTLNG AND SOURCE 
TAGGING 

(a) The replacement of any sealed source 
fastened to or contained in a radiographic exposure 
device and leak testing, repair, tagging, opening or 
any other modification of any sealed source shall 
be performed only by persons specifically 
authorized by the agency to do so. 



(b) Each sealed source shall be tested for 
leakage at intervals not to exceed six months. In 
the absence of a certificate from a transferor that 
a test has been made within the six months prior to 
the transfer, the sealed source shall not be put into 
use until tested. 

(c) The leak test shall be capable of detecting 
the presence of 0.005 microcurie of removable 
contamination on the sealed source. An acceptable 
leak test for sealed sources in the possession of a 
radiography licensee would be to test at the nearest 
accessible point to the sealed source storage 
position, or other appropriate measuring point, by 
a procedure to be approved pursuant to Rule 
.0323(5) of this Chapter. Records of leak test 
results shall be kept in units of microcuries and 
maintained for inspection by the agency for six 
months after the next required leak test is 
performed or until the sealed source is disposed of 
or transferred. 

(d) Any test conducted pursuant to Paragraphs 
(b) and (c) of this Rule which reveals the presence 
of 0.005 microcurie or more of removable 
radioactive material shall be considered evidence 
that the sealed source is leaking. The licensee 
shall immediately withdraw the equipment 
involved from use and shall cause it to be 
decontaminated and repaired or to be disposed of. 



7:19 



NORTH CAROLINA REGISTER 



January 4, 1993 



2118 



PROPOSED RULES 



in accordance with these Regulations Rules . A 
report describing the equipment involved, the test 
results, and the corrective action taken shall be 
submitted in writing to the agency at the address in 
Rule .0111 of this Chapter within five days after 
the test. 

lei A sealed source which is not fastened to or 
contained in a radiographic exposure device shall 
have permanently attached to it a durable tag at 
least one inch square bearing the prescribed 
radiation caution symbol in conventional colors, 
magenta or purple on a yellow background, and at 
least the instructions "Danger - Radioactive 
Material. Do Not Handle. Notify Civil 
Authorities If Found." 

Statutory Authority G.S. 104E-7. 

.0510 LIMITATIONS 

(a) The licensee or registrant shall not permit 
anv person to act as a radiographer until the 
person: 

(1) has been instructed in the subjects 
outlined in Rule .0518 of this Section 
and has demonstrated understanding 
thereof; 

(2) has received copies of and instruction in 
the Rule s rules contained in this Section 
and in the applicable rules of Section 
.0300 and .0900 of this Chapter, and 
the licensee's or registrant's operating 
and emergency procedures, and has 
demonstrated understanding thereof: 

(3) has demonstrated competence to use the 
radiographic exposure devices, sealed 
sources, related handling tools and 
survey instruments which will be 
employed in his assignment: and 

(4) has demonstrated understanding of the 
instructions in Paragraph (a) of this 
Rule by successful completion of a 
written test and a field examination on 
the subjects covered. 

(b) The licensee or registrant shall not permit 
any person to act as a radiographer's assistant until 
the person: 

( 1 ) has received copies of and instructions 
in the licensee's or registrant's 
operating and emergency procedures, 
and has demonstrated understanding 
thereof: 

(2) has demonstrated competence to use 
under the personal supervision of the 
radiographer, the radiographic exposure 
devices. sealed sources. related 



handling tools and radiation survey 
instruments which will be employed in 
his assignment; and 
(3) has demonstrated understanding of the 
instructions in Paragraph (b) of this 
Rule by successfully completing a 
written or oral test and a field 
examination on the subjects covered. 

(c) Records of the training including copies of 
written tests and dates of oral tests and field 
examinations shall be maintained for three years. 

(d) Each licensee or registrant shall conduct an 
internal audit program to ensure that the agency's 
radioactive material license, registration conditions 
and the licensee's or registrant's operating and 
emergency procedures are followed bv each 
radiographer and radiographer's assistant. These 
internal audits shall be performed and records 
maintained as specified in Subparagraphs Sub- 
items (3)(a) and (b) of Rule .0323 of this Chapter. 

Statutory Authority G.S. 104E-7. 

.0518 RADIATION MACHINES 

The following are special requirements for 
radiography employing radiation machines: 

(1) Cabinet radiography using radiation 
machines, as defined in Rule ,0502ff-) of 
this Section shall be exempt from 
requirements of this Section: except that 
no registrant shall permit any individual 
to operate a cabinet radiography unit 
until the individual has received a copy 
of. and instruction in. and demonstrated 
an understanding of operating procedures 
for the unit, and has demonstrated 
competence in its use. 

(2) Shielded Room Radiography using 
radiation machines, as defined in Rule 
.0502-(-g-) of this Section, shall be exempt 
from the requirements of this Section: 
except that: 

(a) No registrant shall permit any 
individual to operate a radiation 
machine for shielded room radiographv 
until the individual has received a copy 
of. and instruction in. and demonstrated 
an understanding of operating 
procedures for the unit, and has 
demonstrated competence in its use. 

(b) Each registrant shall supply appropriate 
personnel monitoring equipment to. and 
shall require the use of such equipment 
by. every individual who operates, who 
makes "set-ups" or who performs 



2119 



7:19 



SORTH CAROLINA REGISTER 



January 4, 1993 



PROPOSED RULES 



maintenance on a radiation machine for 

shielded room radiography. 

(c) A physical radiation survey shall be 

conducted to determine that the 

radiation machine is "off" prior to each 

entry into the shielded room. Such 

surveys shall be made with a radiation 

measuring instrument which is capable 

of measuring radiation of the energies 

and at the exposure rates to be 

encountered, which is in good working 

order, and which has been properly 

calibrated within the preceding three 

months or following the last instrument 

servicing, whichever is later. 

(3) Other radiography using radiation 

machines are exempt from Rules .0503, 

.0505, .0507, and .0508 of this Section; 

however: 

(a) A physical radiation survey shall be 
conducted to determine that the 
radiation machine is "off" prior to each 
entry into the radiographic exposure 
area. Such surveys shall be made with 
a radiation measuring instrument 
capable of measuring radiation of the 
energies and at the exposure rates to be 
encountered, which is in good working 
order, and which has been properly 
calibrated within the preceding three 
months or following the last instrument 
servicing, whichever is later. Survey 
results and records of boundary 
locations shall be maintained and kept 
available for inspection; and 

(b) Mobile or portable radiation machines 
shall be physically secured to prevent 
removal by unauthorized personnel. 

Statutory Authority G.S. 104E-7; 104E-12(a)(l). 

SECTION .0600 - X-RAYS IN THE 
HEALING ARTS 



.0602 DEFINITIONS 

(a) As used in this Section, 
definitions shall apply: 



the following 



( 1 ) "Accessible surface" means the external 
surface of the enclosure or housing 
provided by the manufacturer. 

(2) "Added filter" means the filter added to 
the inherent filtration. 

(3) "Aluminum equivalent" means the 
thickness of aluminum, type 1 100 alloy, 
affording the same attenuation, under 



specified conditions, as the material in 
question. The nominal composition of 
type 1100 aluminum alloy is 99.00 
percent minimum aluminum and 0.12 
percent copper. 

(4) "Attenuation block" means a block or 
stack, having dimensions 20 cm by 20 
cm by 3.8 cm, of type 1100 aluminum 
alloy or other materials having 
equivalent attenuation. 

(5) "Automatic exposure control" means a 
device which automatically controls one 
or more technique factors in order to 
obtain, at a preselected location(s), a 
required quantity of radiation. 
Phototimer is described separately. 

(6) "Beam axis" means a line from the 
source of x-rays through the centers of 
the x-ray fields. 

(7) "Beam-limiting device" means a device 
which provides a means to restrict the 
dimensions of the x-ray field. 

(8) "Cephalometric device" means a device 
intended for the radiographic 
visualization and measurement of the 
dimensions of the human head. 

(9) "Changeable filters" means any added 
filter which can be removed from the 
useful x-ray beam through any 
electronic, mechanical or physical 
process. 

(10) "Contact therapy system" means that 
the x-ray tube target is put within five 
centimeters of the surface being treated. 

(11) "Control panel" means that part of the 
x-ray control upon which are mounted 
the switches, knobs, pushbuttons and 
other hardware necessary for manually 
setting the technique factors. 

(12) "Cooling curve" means the graphical 
relationship between heat units stored 
and cooling time. 

(13) "Dead-man switch" means a switch so 
constructed that a circuit closing contact 
can be maintained only by continuous 
pressure on the switch by the operator. 

(14) "Diagnostic source assembly" means 
the tube housing assembly with a device 
attached. 

(15) "Diagnostic-type protective tube 
housing" means a tube housing so 
constructed that the leakage radiation 
measured at a distance of one meter 
from the source does not exceed 100 
mR in one hour when the tube is 



7:19 



NORTH CAROLINA REGISTER 



January 4, 1993 



2120 



PROPOSED RULES 



operated at its leakage technique 
factors. 

(16) "Diagnostic x-ray system" means an 
x-ray system designed for irradiation of 
any part of the human body for the 
purpose of diagnosis or visualization. 

(17) "Direct scattered radiation" means that 
radiation which has been deviated in 
direction by materials irradiated by the 
useful beam. (See also scattered 
radiation). 

(18) "Entrance exposure rate" means the 
roentgens per unit time at the point 
where the center of the useful beam 
enters the patient. 

(19) "Exposure" means the quotient of dQ 
by dm where "dQ" is the absolute value 
of the total charge of the ions of one 
sign produced in air when all the 
electrons, negatrons and positrons, 
liberated by photons in a volume 
element of air having mass "dm" are 
completely stopped in air. The special 
unit of exposure is the roentgen. 

(20) "Field emission equipment" means 
equipment which uses an x-ray tube in 
which electron emission from the 
cathode is due solely to the action of an 
electric field. 

(21) "Filter" means material placed in the 
useful beam to preferentially attenuate 
selected radiations. 

(22) "Fluoroscopic imaging assembly" 
means a subsystem in which x-ray 
photons produce a fluoroscopic image. 
It includes the image receptor(s) such as 
the image intensifier and spot-film 
device, electrical interlocks and 
structural material providing linkage 
between the image receptor and the 
diagnostic source assembly. 

(23) "General purpose radiographic x-ray 
system" means any radiographic x-ray 
system which, by design, is not limited 
to radiographic examination of specific 
anatomical regions. 

(24) "Gonad shield" means a protective 
barrier used to reduce exposure to the 
testes or ovaries. 

(25) "Half- value layer (HVL)" means the 
thickness of specified material which 
attenuates the beam of radiation to an 
extent such that the exposure rate is 
reduced to one-half of its original 
value. In this definition the 



contribution of all scattered radiation. 
other than any which might be present 
initially in the beam concerned, is 
deemed to be excluded. 

(26) "Healing arts mass screening" means 
the examination of human beings using 
x-rays for the detection or evaluation of 
health indications when such tests are 
not specifically and individually ordered 
by a licensed practitioner of the healing 
arts who is legally authorized to 
prescribe such x-ray tests for the 
purpose of diagnosis or treatment. It 
does not include the use of x-ray tests 
as a requirement for hospital admission 
or as a condition of employment. 

(27) "Image intensifier" means a device, 
including housing, which converts an 
x-ray pattern into a corresponding light 
image of higher energy density. 

(28) "Image receptor" means any device, 
such as fluorescent screen or 
radiographic film, which transforms 
incident x-ray photons either into a 
visible image or into another form 
which can be made into a visible image 
by further transformations. 

(29) "Inherent filtration" means the filtration 
permanently in the useful beam; it 
includes the window of the x-ray tube 
and any permanent tube or source 
enclosure. 

(30) "Installation" means the act of physical 
movement of a radiographic system 
from one location to another in 
conjunction with a change of 
ownership. 

(31) "Lead equivalent" means the thickness 
of lead affording the same attenuation, 
under specified conditions, as the 
material in question. 

(32) "Leakage radiation" means radiation 
emanating from a diagnostic or 
therapeutic source assembly except for: 

(A) the useful beam and 

(B) radiation produced when the exposure 
switch or timer is not activated. 

(33) "Leakage technique factors" means the 
technique factors associated with the 
diagnostic or therapeutic source 
assembly (i.e.. tube housing and beam 
limiting device) which are used in 
measuring leakage radiation. They are 
defined as follows: 

(A) for diagnostic source assemblies 



2121 



7:19 



NORTH CAROLINA REGISTER 



January 4, 1993 



PROPOSED RULES 



intended for capacitor energy storage 
equipment, the maximum rated peak 
tube potential and the maximum rated 
number of exposures in an hour for 
operation at the maximum rated peak 
tube potential with the quantity of 
charge per exposure being 10 
millicoulombs (mC) or the minimum 
obtainable from the unit, whichever is 
larger; 

(B) for diagnostic source assemblies 
intended for field emission equipment 
rated for pulsed operation, the 
maximum rated peak tube potential 
and the maximum rated number of 
x-ray pulses in an hour for operation 
at the maximum rated peak tube 
potential; and 

(C) for all other diagnostic or therapeutic 
source assemblies, the maximum rated 
peak tube potential and the maximum 
rated continuous tube current for the 
maximum rated peak tube potential. 

(34) "Light field" means that area of the 
intersection of the light beam from the 
beam-limiting device and one of the set 
of planes parallel to and including the 
plane of the image receptor, whose 
perimeter is the locus of points at which 
the illumination is one-fourth of the 
maximum in the intersection. 

(35) "Maximum line current" means the rms 
(root-mean-square) current in the 
supply line of an x-ray machine 
operating at its maximum rating. 

(36) "Mobile equipment" (see x-ray 
equipment). 

(37) "Peak tube potential" means the 
maximum value of the potential 
difference across the x-ray tube during 
an exposure. 

(38) "Phototimer" means a method for 
controlling radiation exposures to image 
receptors by the amount of radiation 
which reaches a radiation monitoring 
device(s). The radiation monitoring 
device(s) is part of an electronic circuit 
which controls the duration of time the 
tube is activated (see also "Automatic 
exposure control"). 

(39) "Portable equipment" (see x-ray 
equipment). 

(40) "Position indicating device (PID)" 
means a device on dental x-ray 
equipment used to indicate the beam 



position and to establish a definite 
source-skin distance. It may or may 
not incorporate or serve as a 
beam-limiting device. 

(41) "Primary protective barrier" means the 
material, excluding filters, placed in the 
useful beam, for radiation protection 
purposes, to reduce the radiation 
exposure. 

(42) "Protective apron" means an apron 
made of radiation attenuating materials 
used to reduce radiation exposure. 

(43) "Protective barrier" means a barrier of 
radiation attenuating material(s) used to 
reduce radiation exposure. Types of 
protective barriers are defined in Rules 
other Items of this Rule . .0602( 4 1) and 
.0602(53). 

(44) "Protective glove" means a glove made 
of radiation attenuating materials used 
to reduce radiation exposure. 

(45) "Qualified expert" means an individual 
who has demonstrated to the 
satisfaction of the agency that he 
possesses the knowledge and training to 
measure ionizing radiation parameters, 
to evaluate safety techniques and to 
advise regarding radiation protection 
needs and who is registered pursuant to 
Rule .0205 of this Chapter. 

(46) "Radiograph" means an image receptor 
on which the image has been created 
directly or indirectly by an x-ray 
pattern and results in a permanent 
record. 

(47) "Radiographic imaging system" means 
any system whereby a permanent or 
semi-permanent image is recorded on 
an image receptor by the action of 
ionizing radiation. 

(48) "Rating" means the operating limits as 
specified by the component 
manufacturer. 

(49) "Recording" means producing a 
permanent form of an image resulting 
from x-ray photons such as film and 
video tape. 

(50) "Registrant", as used in this Section, 
means any person who owns or 
possesses and administratively controls 
an x-ray system which is used to 
deliberately expose humans or animals 
to the useful beam of the system and is 
required by the provisions contained in 
Sections .0100 and .0200 of this 



7:19 



NORTH CAROLINA REGISTER 



January 4, 1993 



2122 



PROPOSED RULES 



Chapter to register with the agency. 

(51) "Response time" means the time 
required for an instrument system to 
reach 90 percent of its final reading 
when the radiation-sensitive volume of 
the instrument system is exposed to a 
step change in radiation flux from zero 
sufficient to provide a steady state 
mid-scale reading. 

(52) "Scattered radiation" means radiation 
that, during passage through matter, has 
been deviated in direction. (See also 
"direct scattered radiation".) 

(53) "Secondary protective harrier" means a 
barrier sufficient to attenuate the stray 
radiation to the required degree. 

(54) "SID" means source-image receptor 
distance. 

(55) "Source" means the focal spot of the 
x-ray tube. 

(56) "Source-image receptor distance (SID)" 
means the distance from the source to 
the center of the input surface of the 
image receptor. 

(57) "Spot film" means a radiograph which 
is made during a fluoroscopic 
examination to permanently record 
conditions which exist during that 
fluoroscopic procedure. 

(58) "Stationary equipment" (see x-ray- 
equipment). 

(59) "Stray radiation" means the sum of 
leakage and scattered radiation. 

(60) "Technique factors" means the 
conditions of operation. They are 
specified as follows: 

(A) for capacitor energy storage 
equipment, peak tube potential in kV 
and quantity of charge in mAs; 

(Bi for field emission equipment rated for 
pulsed operation, peak tube potential 
in kV and number of x-ray pulses; 
and 

(C) for all other equipment, peak tube 
potential in kV and either tube current 
in mA and exposure time in seconds, 
or the product of tube current and 
exposure time in mAs. 

(61) "Therapeutic-type protective tube 
housing" means the tube housing with 
tube installed, and it includes high 
voltage and filament transformers and 
other appropriate elements when they 
are contained within that housing. 

(62) "Transportation equipment" means 



x-ray equipment which is installed in a 
vehicle or trailer. 

(63) "Tube" means an x-ray tube, unless 
otherwise specified. 

(64) "Tube housing assembly" means the 
tube housing with tube installed. It 
includes high-voltage and filament 
transformers and other appropriate 
elements when they are contained with- 
in the tube housing. 

(65) "Tube rating chart" means the set of 
curves which specify the rated limits of 
operation of the tube in terms of the 
technique factors. 

(66) "Useful beam" means the radiation 
which passes through the tube housing 
port and the aperture of the 
beam-limiting device when the exposure 
switch or timer is activated. 

(67) "Variable-aperture beam-limiting 
device" means a beam-limiting device 
which has capacity for stepless 
adjustment of the x-ray field size at the 
given SID. 

(68) "Visible area" means that portion of the 
input surface of the image receptor over 
which incident x-ray photons produce a 
visible image. 

(69) "X-ray control" means a device which 
controls input power to the x-ray 
high-voltage generator or the x-ray 
tube. It includes equipment such as 
timers, phototimers, automatic 
brightness stabilizers and similar 
devices which control the technique 
factors of an x-ray exposure. 

(70) "X-ray equipment" means an x-ray 
system, subsystem or component 
thereof. 

(A) "Mobile equipment" means x-ray 
equipment mounted on a permanent 
base with wheels or casters for 
moving while completely assembled. 

(B) "Portable equipment" means x-ray 
equipment designed to be 
hand-carried. 

(C) "Stationary equipment" means x-ray 
equipment which is installed in a 
fixed location. 

(71) "X-ray field" means that area of the 
intersection of the useful beam and any 
one of the set of planes parallel to and 
including the plane of the image 
receptor, whose perimeter is the locus 
of points at which the exposure rate is 



2123 



7:19 



NORTH CAROLINA REGISTER 



January 4, 1993 



PROPOSED RULES 



one-fourth of the maximum in the 
intersection. 

(72) "X-ray high-voltage generator" means 
a device which transforms electrical 
energy from the potential supplied by 
the x-ray control to the tube operating 
potential. The device may also include 
means for transforming alternating 
current to direct current, filament trans- 
formers for the x-ray tube(s), 
high-voltage switches, electrical protec- 
tive devices and other appropriate 
elements. 

(73) "X-ray system" means an assemblage of 
components for the controlled produc- 
tion of x-rays. It includes minimally an 
x-ray high-voltage generator, an x-ray 
control, a tube housing assembly, a 
beam-limiting device and the necessary 
supporting structures. Additional com- 
ponents which function with the system 
are considered integral parts of the 
system. 

(74) "X-ray subsystem" means any combina- 
tion of two or more components of an 
x-ray system for which there are re- 
quirements specified in this Section. 

(75) "X-ray tube" means an electron tube 
which is designed for the conversion of 
electrical energy into x-ray energy. 

(b) Other definitions applicable to this Section 
may be found in Sections .0100 and .0200 of this 
Chapter. 

Statutory Authority G.S. 104E-7. 

.0605 FLUOROSCOPIC X-RAY SYSTEMS 

All fluoroscopic x-ray systems shall meet the 
following requirements: 
(1) Limitation of useful beam 

(a) The fluoroscopic tube shall not produce 
x-rays unless the primary protective 
barrier is in position to intercept the 
entire useful beam at all times. 

(b) The entire cross section of the useful 
beam shall be intercepted by the prima- 
ry protective barrier of the fluoroscopic 
image assembly at any SID. 

(c) Limitation to the Imaging Surface 

(i) The x-ray field produced by fluoro- 
scopic equipment without image 
intensification shall not extend beyond 
the entire visible area of the image 
receptor. This requirement applies to 
field size during both fluoroscopic 



procedures and spot-filming proce- 
dures . 
(ii) Image-intensified fluoroscopy and 
spot-filming shall comply with the 
following: 

(A) During fluoroscopic or 
spot-filming procedures, neither 
the length nor the width of the 
x-ray field in the plane of the 
image receptor shall exceed the 
visible area of the image receptor 
by more than three percent of the 
SID. The sum of the excess 
length and the excess width shall 
be no greater than four percent of 
the SID. 

(B) Compliance shall be determined 
with the beam axis perpendicular 
to the image receptor. For rect- 
angular x-ray fields used with 
circular image reception, the error 
in alignment shall be determined 
along the length and width dimen- 
sions of the x-ray field which pass 
through the center of the visible 
area of the image receptor. 

(iii) In addition to other requirements of 
this Rule, equipment manufactured 
after the effective date of these Rules 
shall comply with the following: 

(A) Means shall be provided between 
the source and the patient for 
adjustment of the x-ray field size 
in the plane of the film to the size 
of that portion of the film which 
has been selected on the spot-film 
selector. This adjustment shall be 
automatically accomplished except 
when the x-ray field size in the 
plane of the film is smaller than 
that of the selected portion of the 
film. 

(B) It shall be possible to adjust the 
x-ray field size in the plane of the 
film to a size smaller than the 
selected portion of the film. The 
minimum field size at the greatest 
SID, shall be equal to or less than 
five centimeters by five centime- 
ters. 

(C) The center of the x-ray field in 
the plane of the film shall be 
aligned with the center of the 
selected portion of the film to 
within two percent of the SID. 



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2124 



PROPOSED RULES 



(2) X-ray production in the fluoroscopic 
mode shall be controlled by a device 
which requires continuous pressure by 
the fluoroscopist for the entire time of 
any exposure. When recording serial 
fluoroscopic images, the fluoroscopist 
shall be able to terminate the x-ray expo- 
sure^) at any time, but means may be 
provided to permit completion of any 
single exposure of the series in process. 

(3) Entrance exposure rates shall be limited 
as required in the following: 

(a) Fluoroscopic equipment shall not be 
operated at any combination of tube 
potential and current which will result 
in an exposure rate in excess of ten 
roentgens per minute at the point where 
the center of the useful beam enters the 
patient, except: 

(i) during recording of fluoroscopic 
images; or 

(ii) when provided with optional high 
level control, the equipment shall not 
be operable at any combination of 
tube potential and current which will 
result in an exposure rate in excess of 
five roentgens per minute at the point 
where the center of the beam enters 
the patient unless the high level con- 
trol is activated. Special means of 
activation of high level controls, such 
as additional pressure applied continu- 
ously by the operator, shall be re- 
quired to avoid accidental use. A 
continuous signal audible to the fluo- 
roscopist shall indicate that the high 
level control is being employed. 

(b) In addition to the other requirements of 
this Rule equipment manufactured after 
August. 1974. which does not incorpo- 
rate an automatic exposure control 
(e.g., automatic brightness control or 
ionization chamber control) shall not be 
operated at any combination of tube 
potential and current which will result 
in an exposure rate in excess of five 
roentgens per minute at the point where 
the center of the useful beam enters the 
patient except during the recording of 
fluoroscopic images or when provided 
with an optional high level control. 

(c) Compliance with the provisions of 
.Subparagraph Item (3) of this Rule shall 
be determined as follows: 

(i) Movable grids and compression devic- 



es shall be removed from the useful 
beam during the measurement. 

(ii) If the source is below the table, the 
exposure rate shall be measured one 
centimeter above the tabletop or 
cradle. 

(iii) If the source is above the table, the 
exposure rate shall be measured at 30 
centimeters above the tabletop with 
the end of the beam-limiting device or 
spacer positioned as closely as possi- 
ble to the point of measurement. 

(iv) In a C-arm type fluoroscope, the 

exposure rate shall be measured 30 

centimeters from the input surface of 

the fluoroscopic imaging assembly. 

(d) Periodic measurement of entrance 

exposure rate limits shall comply with 

the following: 

(i) Such measurements shall be made 
every two years or after any mainte- 
nance of the system which might 
affect the exposure rate. 

(ii) Results of these measurements shall 
be available or posted where any 
fluoroscopist may have ready access 
to them and shall be in the record 
required in Rule .0603(a)(2)(B) of this 
Section. Results of the measurements 
shall include the exposure rate, as 
well as the physical factors used to 
determine all data; the name of the 
person approved by the agency per- 
forming the measurements and the 
date the measurements were 
performed. 

(iii) Entrance exposure rate shall be deter- 
mined with the attenuation block in 
Rule .0602(aH4-) in the primary beam. 
(4) Radiation transmitted through the primary 
protective barrier of the fluoroscopic 
imaging assembly shall comply with the 
following requirements: 

(a) The exposure rate resulting from trans- 
mission through the primary protective 
barrier with the attenuation block in the 
useful beam, combined with radiation 
from the image intensifier. if provided, 
shall not exceed two milliroentgens per 
hour at ten centimeters from any acces- 
sible surface of the fluoroscopic imag- 
ing assembly beyond the plane of the 
image receptor for each roentgen per 
minute of entrance exposure rate. 

(b) Measurements to determine compliance 



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PROPOSED RULES 



with Subparagraph Sub-item (4)(a) of 
this Rule shall be in accordance with 
the following: 

(i) The exposure rate resulting from 
transmission through the primary 
protective barrier combined with 
radiation from the image intensifier 
shall be determined by measurements 
averaged over an area of 100 square 
centimeters with no linear dimension 
greater than 20 centimeters: 

(ii) If the source is below the tabletop, the 
measurement shall be made with the 
input surface of the fluoroscopic 
imaging assembly, positioned 30 
centimeters above the tabletop. 

(iii) If the source is above the tabletop and 
the SID is variable, the measurement 
shall be made with the end of the 
beam-limiting device or spacer as 
close to the tabletop as it can be 
placed, provided that it shall not be 
closer than 30 centimeters; 

(iv) Movable grids and compression devic- 
es shall be removed from the useful 
beam during the measurement; 

(v) The attenuation block shall be posi- 
tioned in the useful beam ten centime- 
ters from the point of measurement of 
entrance exposure rate and between 
this point and the input surface of the 
fluoroscopic imaging assembly. 

(5) During fluoroscopy and cinefluorogra- 
phy, x-ray tube potential and current 
shall be continuously indicated. 

(6) The source-skin distance shall not be less 
than: 

(a) 38 centimeters on stationary fluoro- 
scopes. 

(b) 30 centimeters on all mobile fluoro- 
scopes, or 

(c) 20 centimeters for image intensified 
fluoroscopes during surgical applica- 
tion. 

(7) Fluoroscopic timers shall meet the fol- 
lowing requirements: 

(a) Means shall be provided to preset the 
cumulative on-time of the fluoroscopic 
tube. The maximum cumulative time 
of the timing device shall not exceed 
five minutes without resetting. 

(b) A signal audible to the fluoroscopist 
shall indicate the completion of any 
preset cumulative on-time. Such signal 
shall continue to sound while x-rays are 



produced until the timing device is reset. 

(8) Mobile fluoroscopes, in addition to the 
other requirements of this Rule, shall 
provide image intensification. 

(9) Scattered radiation shall be controlled in 
accordance with the following require- 
ments: 

(a) A shielding device of at least 0.25 mm 
lead equivalent for covering the Bucky 
slot during fluoroscopy shall be provid- 
ed. 

(b) A shield of at least 0.25 mm lead 
equivalent, such as overlapping protec- 
tive drapes or hinged or sliding panels, 
shall be provided to intercept scattered 
radiation which would otherwise reach 
the fluoroscopist and others near the 
machine. 

(c) Upon application to the agency with 
adequate justification, exceptions from 
Subparagraphs Sub-items (9)(a) or 
(9)(b) of this Rule may be made in 
some special procedures where a sterile 
field will not permit the use of the 
normal protective barriers or where the 
protective barriers would interfere with 
the procedures. 

Statutory Authority G.S. 104E-7. 

.0606 SYSTEMS OTHER THAN 

FLUOROSCOPIC AND DENTAL 
INTRAORAL 

(a) Unless specifically provided otherwise by the 
Rule s rules in this Chapter, the requirements in 
this Rule shall apply to all x-ray systems, except 
for fluoroscopic and dental intraoral x-ray systems. 
The useful beam of x-ray systems subject to 
provisions of this Rule shall be limited to the area 
of clinical interest or the image receptor, whichev- 
er is smaller. 

(1) General purpose stationary and mobile 

x-ray systems shall meet the following 

special requirements: 

(A) There shall be provided a means for 
stepless adjustment of the size of the 
x-ray field. The minimum field size 
at a SID of 100 centimeters shall be 
equal to or less than five centimeters 
by five centimeters. 

(B) Means shall be provided for visually 
defining the perimeter of the x-ray 
field. The total misalignment of the 
edges of the visually defined field 
with the respective edges of the x-ray 



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2126 



PROPOSED RULES 



field along either the length or width 
of the visually defined field shall not 
exceed two percent of the distance 
from the source to the center of the 
visually defined field when the surface 
upon which it appears is perpendicu- 
lar to the axis of the x-ray beam. 
(C) Notwithstanding Subparagraphs Parts 
(a)(1)(A) and (B) of this Rule, equip- 
ment manufactured before August 1 . 
1974 may employ fixed cones and 
diaphragms or variable collimators 
without beam defining lights. 

(2) In addition to the requirements of Sub- 
paragraph (a)(1) of this Rule, all sta- 
tionary x-ray systems, except equipment 
originally manufactured before the 
effective date of this Rule, shall meet 
the following requirements: 

(A) Means shall be provided to indicate 
when the axis of the x-ray beam is 
perpendicular to the plane of the 
image receptor, to align the center of 
the x-ray field with respect to the 
center of the image receptor to within 
two percent of the SID. and to indi- 
cate the SID to within two percent; 

(B) The beam limiting device shall nu- 
merically indicate the field size in the 
plane of the image receptor to which 
it is adjusted; 

(C) Indication of field size dimensions and 
SID"s shall be specified in inches or 
centimeters and shall be such that 
aperture adjustments result in x-ray 
field dimensions in the plane of the 
image receptor which correspond to 
those of the image receptor to within 
two percent of the SID when the 
beam axis is perpendicular to the 
plane of the image receptor. 

(3) Radiographic equipment designed for 
only one image receptor size at a fixed 
SID shall be provided with means to 
limit the field at the plane of the image 
receptor to dimensions no greater than 
those of the image receptor and to align 
the center of the x-ray field with the 
center of the image receptor to within 
two percent of the SID. 

(4) Special purpose x-ray systems shall 
meet the following requirements: 

(A) These systems shall be provided with 
means to limit the x-ray field in the 
plane of the image receptor so that 



such field does not exceed each di- 
mension of the image receptor by 
more than two percent of the SID 
when the axis of the x-ray beam is 
perpendicular to the plane of the 
image receptor. 

(B) Such systems shall also be provided 
with means to align the center of the 
x-ray field with the center of the 
image receptor to within two percent 
of the SID. 

(C) The requirements in Subparagraphs 
Parts (a)(4)(A) and (B) of this Rule 
may be met with a system that meets 
the requirements for a general pur- 
pose x-ray system as specified in 
Subparagraph (a)(1) of this Rule or, 
when alignment means are also pro- 
vided, as follows: 

(i) an assortment of removable, 
fixed-aperture. beam-limiting 
devices sufficient to meet the 
requirement for each combination 
of image receptor size and SID 
for which the unit is designed, 
where each device has clear and 
permanent markings to indicate 
the image receptor size and SID 
for which it is designed; or 
(ii) a beam-limiting device having 
multiple fixed apertures sufficient 
to meet the requirement for each 
combination of image receptor 
size and SID for which the unit is 
designed, where the device has 
permanent, clearly legible, mark- 
ings indicating image receptor 
size and SID for which the unit is 
designed, where the device has 
permanent, clearly legible, mark- 
ings indicating image receptor 
size and SID for which each 
aperture is designated and indicat- 
ing which aperture is in position 
for use. 
(b) Radiation exposure control devices shall 
meet the following requirements: 

( 1 ) Means shall be provided to terminate 
the exposure after a preset time inter- 
val, preset product of current and time, 
a preset number of pulses or a preset 
radiation exposure to the image recep- 
tor. In addition: 
(A) Termination of exposure shall cause 
automatic resettina of the timer to its 



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PROPOSED RULES 



initial setting or to zero except during 
serial radiography, and 
(B) It shall not be possible to make an 
exposure when the timer is set to a 
zero or "off" position if either posi- 
tion is provided. 

(2) Control over x-ray exposures shall be 
in accordance with the following re- 
quirements: 

(A) A control shall be incorporated into 
each x-ray system such that the opera- 
tor can terminate an exposure at any 
time except for serial radiography 
where means may be provided to 
permit completion of any single expo- 
sure of the series in process. 

(B) Each x-ray control shall be located in 
such a way as to meet the following 
criteria. 

(i) For stationary x-ray systems, the 
control shall be permanently 
mounted in a protected area so 
that the operator is required to 
remain in that protected area 
during the entire exposure; and 

(ii) The x-ray control shall provide 
visual indication observable at or 
from the operator's protected 
position whenever x-rays are 
produced. In addition, except for 
equipment originally manufac- 
tured before the effective date of 
this Rule, a signal audible to the 
operator shall indicate that the 
exposure has terminated. 

(3) When an automatic exposure control 
(e.g., phototimer) is provided the fol- 
lowing requirements shall be met, 
except equipment originally manufac- 
tured before the effective date of this 
Rule: 

(A) Indication shall be made on the con- 
trol panel when this mode of opera- 
tion is selected; 

(B) When the x-ray tube potential is equal 
to or greater than 50 kVp, the mini- 
mum exposure time for field emission 
equipment rated for pulsed operation 
shall be equal to or less than a time 
interval equivalent to two pulses; 

(C) The minimum exposure time for all 
equipment other than that specified in 
Subparagraph Part (b)(3)(B) of this 
Rule shall be equal to or less than 
1/60 second or a time interval re- 



quired to deliver five mAs, whichever 
is greater; 

(D) Either the product of peak x-ray tube 
potential, current and exposure time 
shall be limited to not more than 60 
kWs per exposure or the product of 
x-ray tube current and exposure time 
shall be limited to not more than 600 
mAs per exposure except when the 
x-ray tube potential is less than 50 
kVp, in which case the product of 
x-ray tube current and exposure time 
shall be limited to not more than 2000 
mAs per exposure; and 

(E) A visible signal shall indicate when an 
exposure has been terminated at the 
limits described in Subparagraph Part 
(b)(3)(D) of this Rule and manual 
resetting shall be required before 
further automatically timed exposures 
can be made. 

(4) When four timer tests are performed at 
identical timer setting equal to 5.0 
seconds or less, the average time period 
(T) shall be greater than five times the 
difference between the maximum period 
(T max ) and the minimum period (T^ in 
accordance with the formula: 

T > 5(T mar T mm ) 

(c) Source-skin or source-image receptor dis- 
tance shall meet the following requirement: 

All radiographic systems shall be provided 
with a durable, securely fastened means to 
limit the source-skin distance to at least 30 
centimeters. This is considered to be met 
when the collimator or cone provides the 
required limits. 

(d) The exposure produced shall be reproducible 
to within the following criteria: 

When all technique factors are held con- 
stant, the coefficient of variation shall not 
exceed 0.10. This shall be deemed to be 
met if. when four exposures at identical 
technique factors are made, the value of 
the average exposure (E)is greater than 
five times the difference between the 
maximum exposure (E max ) and the mini- 
mum exposure (E mn ) in accordance with 
the formula: 

E > 5(E -E ) 

(e) Standby radiation from capacitor energy 



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January 4, 1993 



2128 



PROPOSED RULES 



storage equipment, when the exposure switch or 
timer is not activated, shall not exceed a rate of 
two milliroentgens per hour at five centimeters 
from any accessible surface of the diagnostic 
source assembly with the beam-limiting device 
fully open. 

(f) Linearity 

(1) When the equipment allows a choice of 
x-ray tube current settings, the average 
ratios of exposure to the indicated 
milliampere-seconds product, i.e., 
mR/mAs, obtained at any two consecu- 
tive tube current settings shall not differ 
by more than 0.10 times their sum. 
i.e., /mean of x,- x 2 / < minus 0.10 
mean of (x,+ x 2 ), where the mean of 
x,and x^are the average mR/mAs values 
obtained at each of two consecutive 
tube current settings. 

(2) Compliance shall be determined at the 
most commonly used mA stations by 
measuring mR/mAs at those stations 
and at one adjacent station to each. 

(g) Timer accuracy 

(1) For indicated values of 0.10 seconds 
and above, the measured value shall be 
within plus or minus 15 percent of the 
indicated values for equipment manu- 
factured before August 1. 1974. 

(2) For equipment manufactured after 
August 1, 1974, the deviation of mea- 
sured values from indicated values shall 
not exceed the limits specified for that 
system by its manufacturer. 

Statutory Authority G.S. 104E-7. 

SECTION .0700 - USE OF SEALED 

RADIOACTIVE SOURCES IN THE 

HEALING ARTS 

.0701 SCOPE 

The provisions of this Section apply to all licens- 
ees who use sealed sources in the healing arts and 
are in addition to. and not in substitution for, other 
applicable provisions of the Rule s rules of this 
Chapter. 

Statutory Authority- G.S. 104E-7. 

.0703 TELETHERAPY 

(a) Any licensee authorized under Rule .0322 of 
this Chapter to use teletherapy units for treating 
humans shall cause full calibration measurements 
to be performed on each teletherapy unit. 



( 1 ) Such measurement shall be done at all 
of the following times: 

(A) prior to the first use of the unit for 
treating humans; 

(B) prior to treating humans whenever: 
(i) spot-check measurements indicate 

that the output value differs by 
more than five percent from the 
value obtained at the last full 
calibration corrected mathemati- 
cally for physical decay, or 

(ii) following replacement of the 
radiation source or following 
reinstallation of the teletherapy 
unit in a new location, or 

(iii) following any repair of the tele- 
therapy unit that includes removal 
of the source or major repair of 
the components associated with 
the source exposure assembly; and 

(C) at intervals not exceeding one year. 

(2) Full calibration measurements required 
by Subparagraph (a)(1) of this Rule 
shall include determination of: 

(A) the exposure rate or dose rate to an 
accuracy within plus or minus three 
percent for the range of field sizes 
and for the range of distances (or for 
the axis distance) used in radiation 
therapy; 

(B) the congruence between the radiation 
field and the field indicated by the 
light beam localizing device; 

(C) the uniformity of the radiation field 
and its dependence upon the orienta- 
tion of the useful beam; 

(D) timer accuracy; and 

(E) the accuracy of all distance-measuring 
devices used for treating humans. 

(3) Full calibration measurements shall be 
made in accordance with the procedures 
recommended by the Scientific Commit- 
tee on Radiation Dosimetry of the 
American Association of Physicists in 
Medicine (Physics in Medicine and 
Biology. Vol. 16. No. 3. 1971. pp. 
379-396). 

(4) The exposure rate or dose rate values 
determined in Subparagraph Part 
(a)(2)(A) of this Rule shall be corrected 
mathematically for physical decay for 
intervals not exceeding one month. 

(5) Full calibration measurements required 
by Subparagraph (a)(1) of this Rule and 
physical decay corrections required by 



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PROPOSED RULES 



Subparagraph (a)(4) of this Rule shall 
be performed by an expert qualified by 
training and experience in accordance 
with Subparagraph (d)(1) of this Rule. 

(b) Any licensee authorized under Rule .0322 of 
this Chapter to use teletherapy units for treating 
humans shall cause spot-check measurements to be 
performed on each teletherapy unit at intervals not 
exceeding one month. 

( 1 ) Required spot-check measurements shall 
include determination of: 

(A) timer accuracy; 

(B) the congruence between the radiation 
field and the field indicated by the 
light beam localizing device; 

(C) the accuracy of all distance-measuring 
devices used for treating humans; 

(D) the exposure rate, dose rate, or a 
quantity related in a known manner to 
these rates for one typical set of 
operating conditions; and 

(E) the difference between the 
measurement made in Subparagraph 
Part (b)(1)(D) of this Rule and the 
anticipated output, expressed as a 
percentage of the anticipated output 
(i.e., the value obtained at last full 
calibration corrected mathematically 
for physical decay). 

(2) Required spot-check measurements shall 
be performed in accordance wttk with 
procedures established by an expert 
qualified by training and experience in 
accordance with Paragraph (d) of this 
Rule. 

(c) Any licensee responsible for the performance 
of full calibration and/ or spot-check measurements 
shall be required to calibrate the instruments used 
in making such determinations. 

(1) Full calibration measurements required 
by Paragraph (a) of this Rule shall be 
performed using a dosimetry system 
that has been calibrated by the National 
Bureau of Standards or by a Regional 
Calibration Laboratory accredited by 
the American Association of Physicists 
in Medicine. The dosimetry system 
shall have been calibrated within the 
previous two years and after any 
servicing that may have affected system 
calibration. 

(2) Spot-check measurements required by 
Paragraph (b) of this Rule shall be 
performed using a dosimetry system 
that has been calibrated in accordance 



with Subparagraph (c)(1) of this Rule. 

Alternatively, a dosimetry system used 

solely for spot-check measurements 

may be calibrated by direct 

intercomparison with a system that has 

been calibrated in accordance with 

Subparagraph (c)(1) of this Rule. This 

alternative calibration method shall 

have been performed within the 

previous one year and after each 

servicing that may have affected system 

calibration. Dosimetry systems 

calibrated by this alternative method 

shall not be used for full calibration 

measurements. 

(d) The licensee shall determine if a person is an 

expert qualified by training and experience to 

calibrate a teletherapy unit and establish 

procedures for and review the results of spot-check 

measurements. 

(1) The licensee shall determine that the 
expert is qualified by his: 

(A) being certified by the American Board 
of Radiology in therapeutic 
radiological physics, radiological 
physics, roentgen-ray and gamma-ray 
physics, or x-ray and radium physics; 
or 

(B) having the following minimum 
training and experience: 

(i) a master's or doctor's degree in 
physics, biophysics, radiological 
physics or health physics; 

(ii) one year of full-time training in 
therapeutic radiological physics; 
and 

(iii) one year of full-time experience in 
a radiotherapy facility including 
personal calibration and spot 
check of at least one teletherapy 
unit. 

(2) The licensee who has his teletherapy 
units calibrated by persons who do not 
meet the criteria for minimum training 
and experience stated in Subparagraph 
Part (d)(1)(B) of this Rule may request 
a license amendment excepting them 
from these requirements. 

(A) Such request shall include: 

(i) the name of the proposed 

qualified expert; 
(ii) a description of his training and 
experience including information 
similar to that specified in 
Subparagraph Part (d)(1)(B) of 



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2130 



PROPOSED RULES 



this Rule; 

(iii) reports of at least one calibration 
and spot-check program based on 
measurements personally made by 
the proposed expert within the last 
ten years; and 

(iv) written endorsement of the 
technical qualifications of the 
proposed expert from personal 
knowledge by a physicist certified 
by the American Board of 
Radiology in one of the 
specialities listed in Subparagraph 
Part (d)(1)(A) of this Rule. 

(B) The individual's qualifications will be 
evaluated by the Division of Radiation 
Protection. North Carolina 
Department of Environment, Health, 
and Natural Resources. 

(C) The amendment request must be 
addressed to the agency at the address 
found in Rule .0111 of this Chapter. 

(e) The licensee shall maintain, for inspection by 
the agency, records of the measurements, tests, 
corrective actions, and instrument calibrations 
made under Paragraphs (a), (b), and (c) of this 
Rule, and records of the licensee's evaluation of 
the qualified expert's training and experience made 
under Paragraph (d) of this Rule for the following 
periods of time: 

( 1 ) Records of the full calibration 
measurements under Paragraph (a) of 
this Rule and the calibration of the 
instruments used to make these 
measurements under Paragraph (c) of 
this Rule shall be preserved for five 
years after completion of the 
calibration. 

(2) Records of the spot-check 
measurements and corrective actions 
under Paragraph (b) of this Rule and 
the calibration of instruments used to 
make spot-check measurements under 
Paragraph (c) of this Rule shall be 
preserved for two years after 
completion of the spot-check 
measurements and corrective actions. 

(3) Records of the licensee's evaluation of 
the qualified expert's training and 
experience under Paragraph (d) of this 
Rule shall be preserved for five years 
after the qualified expert's last 
performance of a full calibration on the 
licensee's teletherapy unit. 

(f) Each teletherapy room shall be equipped with 



a radiation monitoring device which continuously 
monitors the teletherapy beam condition and is 
equipped with a back-up battery power supply for 
emergency operation. 

( 1 ) This device shall energize a visible 
signal to make the operator 
continuously aware of teletherapy beam 
conditions in order that appropriate 
emergency procedures may be instituted 
to prevent unnecessary radiation 
exposure. 

(2) Operating procedures shall be modified 
to require daily operational testing of 
the installed radiation monitor. 

(3) If a radiation monitor is inoperable for 
any reason, any person entering the 
teletherapy room shall use a properly 
operating portable radiation survey 
instrument or a personal dosimeter with 
an audible alarm to monitor for any 
malfunction of the source exposure 
mechanism which may have resulted in 
an exposed or partially exposed source. 

(4) Survey instruments or dosimeters shall 
be tested daily before use. 

(g) The licensee shall cause each teletherapy unit 
used to treat humans to be fully inspected and 
serviced during source replacement or at intervals 
not to exceed five years, whichever comes first, to 
assure proper functioning of the source exposure 
mechanism. 

(h) Inspection and servicing of the teletherapy 
unit shall be performed by persons specifically 
authorized to perform such services by a specific 
license issued by the agency, the U.S. Nuclear 
Regulatory Commission or an agreement state. 

Statutory Authority- G.S. W4E-7fa)(2). 

SECTION .0900 - REQUIREMENTS FOR 
PARTICLE ACCELERATORS 

.0902 LICENSING REQUIREMENTS 

No person shall receive, possess, use, transfer, 
own, or acquire a particle accelerator except as 
authorized in a license issued pursuant to these 
Regulations Rules or as otherwise provided for in 
these Regulations Rules . The general procedures 
for licensing of particle accelerator facilities are 
included in Section .0903 of this Chapter. 

Statutory Authority- G.S. 104E-7. 

SECTION .1000 - NOTICES: 
INSTRUCTIONS: REPORTS AND 



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PROPOSED RULES 



INSPECTIONS 

.1001 SCOPE 

This Section establishes requirements for notices, 
instructions and reports by licensees or registrants 
to individuals engaged in work under a license or 
registration and options available to such 
individuals in connection with agency inspections 
of licensees or registrants to ascertain compliance 
with the provisions of the Act and rules, orders 
and licenses issued thereunder regarding 
radiological working conditions. The regulations 
rules in this Section apply to all persons who 
receive, possess, use, own or transfer sources of 
radiation licensed by or registered with the agency 
pursuant to the Regulations rules in Sections 
.0200, .0300, .0900 and .1200 of this Chapter. 

Statutory Authority G.S. 104E-7; 104E-12. 

.1006 CONSULTATION WITH WORKERS 

(a) Agency inspectors may consult privately with 
workers concerning matters of occupational 
radiation protection and other matters related to 
applicable provisions of this Chapter and licenses 
to the extent the inspectors deem necessary for the 
conduct of an effective and thorough inspection. 

(b) During the course of an inspection any 
worker may bring privately to the attention of the 
inspectors, either orally or in writing, any past or 
present condition which he has reason to believe 
may have contributed to or caused any violation of 
the Act, provisions of this Chapter, or license 
condition, or any unnecessary exposure of an 
individual to radiation from licensed radioactive 
material or a registered radiation machine under 
the licensee's or registrant's control. Any such 
notice in writing shall comply with the 
requirements of Rule .1007 of this Section. 

(c) The provisions of Paragraph (b) of this Rule 
shall not be interpreted as authorization to 
disregard instructions pursuant to Rule .1003 of 
this Section. 

Statutory Authority G.S. 104E-7; 104E-10. 

SECTION .1100- FEES 

.1102 PAYMENT DUE 

(a) All fees established in this Section shall be 
due on the effective date of this Rule and on the 
first day of July of each subsequent year. 

(b) Notwithstanding Paragraph (a) of this Rule, 
when a new license or registration is issued by the 
agency after the first day of July of any year, the 



initial fee shall be due on the date of issuance of 
the license or registration. 

(c) The initial fee in Paragraph (b) of this Rule 
shall be computed as follows: 

( 1 ) When any new license or registration is 
issued before the first day of January of 
any year, the initial fee shall be the full 
amount specified in Rule .1105 of this 
Section; and 

(2) When any new license or registration is 
issued on or after the first day of 
January of any year, the initial fee shall 
be one-half of the amount specified in 
Rule .1105 of this Section. 

(d) All fees received by the agency pursuant to 
provisions of this Section shall be nonrefundable. 

(e) Each licensee or registrant shall pay all fees 
by check or money order made payable to 
"Division of Radiation Protection" and mail such 
payment to: Division of Radiation Protection, 
North Carolina Department of Environment, 
Health, and Natural Resources, P. O. Box 27687, 
Raleigh, North Carolina 27611-7687. Such 
payment may be delivered to the agency at its 
office located at 3825 Barrett Drive, Raleigh, 
North Carolina 27609-7221. 

Statutory Authority G.S. I04E-9(8); 104E-19(a). 

. 1 103 NOTICES OF PAYMENT DUE 

Within five days after the due dates established 
in Paragraphs (a) and (b) of Rule .1102 of this 
Section, the agency shall mail to each licensee and 
registrant, who has not already submitted payment, 
a notice which indicates the due date, delinquent 
date and the amount of fees due. 

Statutory Authority G.S. 104E-9(8); 104E-19(a). 

.1104 DELINQUENT AND 

UNCOLLECTIBLE FEES 

(a) Payment of fees established in this Section 
shall be delinquent, if not received by the agency 
within 60 days after the due date specified in 
Paragraphs (a) and (b) of Rule .1102 of this 
Section. 

(b) If a licensee or registrant remits a fee in the 
form of a check or other instrument which is 
uncollectible from the paying institution, the 
agency shall notify the licensee or registrant by 
certified mail and allow the licensee or registrant 
15 days to correct the matter. 

(c) If payment of fees is uncollectible from the 
paying institution or not submitted to the agency 
by the delinquent date, the agency may institute 



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appropriate legal action to collect. 

Statutory Authority G.S. W4E-9(8); 104E-19(a). 

SECTION .1200 - LAND DISPOSAL OF 
RADIOACTIVE WASTE 

.1202 DEFINITIONS 

As used in this Section, the following definitions 
shall apply. 

(1) "Active maintenance" means any 
significant remedial activity needed 
during the period of institutional control 
to maintain a reasonable assurance that 
the performance objectives in Rules 
.1223 and .1224 of this Section are met. 
Such active maintenance includes ongoing 
activities such as the pumping and 
treatment ot water from a disposal unit or 
one-time measures such as replacement of 
disposal unit cover. Active maintenance 
does not include custodial activities such 
as repair of fencing. repair or 
replacement of monitoring equipment, 
revegetation. minor additions to soil 
cover, minor repair of disposal unit 
covers, and general disposal site upkeep 
such as mowing grass. 

(2) "Buffer zone" is a portion of the disposal 
site that is controlled by the licensee and 
that lies under the disposal units and 
between the disposal units and the 
boundary of the site. 

(3) "Chelating agent" means amine 
polycarboxylic acids (e.g.. EDTA, 
DTPA). hydroxy-carboxylic acids, and 
polycarboxylic acids (e.g.. citric acid, 
carbolic acid, and gluconic acid). 

(4) "Commencement of construction" means 
clearing of land, excavation, or other 
substantial action that would adversely 
affect the environment of a land disposal 
facility. The term does not mean 
disposal site exploration, necessary roads 
for disposal site exploration, borings to 
determine foundation conditions, or other 
preconstruction monitoring or testing to 
establish background information related 
to the suitability of the disposal site or 
the protection of environmental values. 

(5) "Custodial agency" means the North 
Carolina Low-Level Radioactive Waste 
Management Authority. 

(6) "Disposal" means the isolation of waste 
from the biosphere inhabited by man and 



his food chains by emplacement in a land 
disposal facility. 

(7) "Disposal site" means that portion of a 
land disposal facility which is used for 
disposal of waste. It consists of disposal 
units and a buffer zone. 

(8) "Disposal system" means the components 
relied on to ensure that the land disposal 
facility meets the performance objectives 
and other requirements of this Section. 
These components include the site and its 
characteristics, the facility and disposal 
unit design, and engineered barriers 
therein, the waste, facility operations and 
closure, intruder barriers and institutional 
control. 

(9) "Disposal unit" means a discrete portion 
of the disposal site into which waste is 
placed for disposal. For near-surface 
disposal, the disposal unit is usually a 
trench. 

(10) "Engineered barrier" means engineered 
barrier as defined in G.S. 104E-5(7a). 

(11) "Explosive material" means any chemical 
compound, mixture, or device, which 
produces a substantial instantaneous 
release of gas and heat spontaneously or 
by contact with sparks or flame. 

(12) "Government agency" means any 
executive department. commission, 
independent establishment. or 
corporation, wholly or partly owned by 
the United States of America or the State 
of North Carolina and which is an 
instrumentality of the United States or the 
State of North Carolina; or any board, 
bureau, department, division, service, 
office, officer, authority, administration, 
or other establishment in the executive 
branch of the government. 

(13) "Hazardous waste" means those wastes 
designated as hazardous by U.S. 
Environmental Protection Agency 
regulations in 40 CFR Part 261. 

(14) "Hydrogeologic unit" means any soil or 
rock unit or zone which by virtue of its 
porosity or permeability, or lack thereof, 
has a distinct influence on the storage or 
movement of groundwater. 

(15) "Inadvertent intruder" means a person 
who might occupy the disposal site after 
closure and engage in normal activities, 
such as agriculture. dwelling 
construction, or other pursuits in which 
the person might be unknowingly 



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exposed to radiation from the waste. 

(16) "Intruder barrier" means a sufficient 
depth of cover over the waste that 
inhibits contact with waste and helps to 
ensure that radiation exposures to an 
inadvertent intruder will meet the 
performance objectives set forth in this 
Section, or engineered structures that 
provide equivalent protection to the 
inadvertent intruder. 

(17) "Institutional control" means control of 
the site after the site is closed and 
stabilized and responsibility for all 
disposed waste and site maintenance is 
assumed by the custodial agency. 

(18) "Land disposal facility" means low-level 
radioactive waste disposal facility as 
defined in G.S. 104E-5(9c). 

(19) "Low-level radioactive waste" means 
low-level radioactive waste as defined in 
G.S. 104E-5(9a) and includes naturally 
occurring and accelerator produced 
radioactive material which is not subject 
to regulation by the U.S. Nuclear 
Regulatory Commission under the 
Atomic Energy Act of 1954. as amended, 
and is suitable for land disposal under the 
provisions in this Section. 

(20) "Mixed waste" means waste that satisfies 
the definition of low-level radioactive 
waste in Subparagraph Item (19) of this 
Rule and contains hazardous waste that 
either: 

(a) is listed as a hazardous waste in 
Subpart D of 40 CFR Part 261 or 

(b) causes the low-level radioactive waste 
to exhibit any of the hazardous waste 
characteristics identified in Subpart C 
of 40 CFR Part 261. 

(21) " Monitoring" means observing and 
making measurements to provide data to 
evaluate the performance and 
characteristics of the disposal site. 

(22) "Near-surface disposal facility" means a 
land disposal facility in which waste is 
disposed of within approximately the 
upper 30 meters of the earth's surface. 

(23) "Reconnaissance level information" is 
any information or analysis that can be 
retrieved or generated without the 
performance of new comprehensive 
s i te- s pec i f i c investigations. 
Reconnaissance level information 
includes but is not limited to drilling 
records required by state agencies, other 



Divisions of this Department, and other 
relevant published scientific literature. 

(24) "Retrieval" means a remedial action for 
removal of Class B and C waste from a 
disposal unit. 

(25) "Shallow land burial" means shallow land 
burial as defined in G.S. 104E-5(14a). 

(26) "Site closure and stabilization" means 
those actions that are taken upon 
completion of operations that prepare the 
disposal site for custodial care and that 
assure that the disposal site will remain 
stable and will not need ongoing active 
maintenance. 

(27) "State" means the State of North 
Carolina. 

(28) "Surveillance" means monitoring and 
observation of the disposal site for 
purposes of visual detection of need for 
maintenance, custodial care, evidence of 
intrusion, and compliance with other 
license and regulatory requirements. 

(29) "Waste" means low-level radioactive 
waste that is acceptable for disposal in a 
land disposal facility. For the purpose of 
this Section, the words "waste" and 
"low-level radioactive waste" have the 
same meaning. 

Statutory Authority G.S. 104E-5; 104E-7; 104E-W; 
104E-25. 

.1203 LICENSE REQUIRED 

(a) No person may receive, possess, and dispose 
of waste from other persons at a land disposal 
facility unless authorized by a license issued by the 
agency pursuant to the Rules rules in this Section 
and the Rule s rules in Section .0300 of this 
Chapter. 

(b) Each person shall file an application with the 
agency pursuant to Rule .0317 of this Chapter and 
obtain a license as provided in this Section before 
commencement of construction of a land disposal 
facility. Failure to comply with this requirement 
may be grounds for denial of a license. 



Statutory Authority G.S. 
104E-25; 104E-26. 



I04E-7; W4E-10(b); 



.1205 GENERAL INFORMATION 

(a) The general information shall include each of 
the following: 

(1) identity of the applicant including: 
(A) the full name, address, telephone 
number, and description of the 



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business or occupation of the 
applicant; 

(B) if the applicant is a partnership, the 
name and address of each partner and 
the principal location where the 
partnership does business; 

(C) if the applicant is a corporation or an 
unincorporated association, 

li) the state where it is incorporated 
or organized and the principal 
location where it does business, 
and 

(ii) the names and addresses of its 
directors and principal officers; 

(D) if the applicant is acting as an agent 
or representative of another person in 
filing the application, all information 
required under this Paragraph shall be 
supplied with respect to the other 
person; and 

(E) if the applicant proposes to contract 
the operation of the disposal facility 
to another person, the full name, 
address, and telephone number of the 
management contractor, the full name 
and address of each applicable 
principal, partner, or director of the 
contractor, the state where it is 
organized, and the principal location 
where it does business; 

(2) qualifications of the applicant: 

(A) the applicable organizational structure 
of the applicant, both off site and on 
site, including a description of lines of 
authority and assignments of 
responsibilities, whether in the form 
of administrative directives, contract 
provisions, or otherwise; 

(B) the technical qualifications, including 
training, experience, and professional 
licensure, registration or certification 
of the applicant and members of the 
applicant's staff to engage in the 
proposed activities, to include the 
minimum training, experience, and 
professional licensure, registration or 
certification requirements for 
personnel filling key positions 
described in Subparagraph Part 
(a)(2)(A) of this Rule: 

(C) a description of the applicant's 
personnel training program; 

(D) the plan to maintain an adequate 
complement of trained personnel on 
site to carry out waste receipt. 



handling, and disposal operations in a 
safe manner; 

(E) prior experience in the generation, 
processing, use. transportation or 
disposal of radioactive material or in 
the treatment, storage, transportation 
or disposal of hazardous waste 
including copies of all notices of 
violations; assessments of any 
administrative, civil, criminal or other 
penalties in connection therewith; and 
all information as to any finding or 
determination that the applicant 
engaged in any of the above 
mentioned activities without having in 
effect any license or permit required 
for such activity: 

(F) disclosure of any prior determination 
of civil or criminal liability with 
respect to any other federal or state 
law or regulation, including but not 
limited to any law or regulation 
governing the transfer of securities, 
which may reflect on the applicant's 
character, reputation or ability to 
comply with all requirements imposed 
on a licensee; and 

(G) upon request by the agency, a copy of 
any application which the applicant 
may previously have submitted for 
any license or permit required for any 
activity listed in Subparagraph Part 
(a)(2)(E) of this Rule; information as 
to the disposition of such application 
including a copy of the license or 
permit. information as to any 
restriction, suspension, revocation or 
cancellation of any such license or 
permit; and any other information 
which may be requested by the 
agency as to the applicant's 
experience and operating practices 
with respect to the activities listed in 
Subparagraph Pail (a)(2)(E) of this 
Rule: 

(3) a description of: 

(A) the location of the proposed disposal 
site; 

(B) the general character of the proposed 
activities; 

(C) the types and quantities of waste to be 
received, possessed, and disposed of; 

(D) plans for use of land disposal facility 
for purposes other than disposal of 
wastes during operation, after closure 



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PROPOSED RULES 



or both; 

(E) the proposed facilities and equipment; 

(F) the proposed manifest and recording 
system; 

(G) the treatment of any waste to be 
shipped off site; 

(H) anticipated operating life of the 

facility; and 
(I) the prelicensing and operational public 
information program which addresses 
(i) state and local government; 
(ii) media and public; 
(iii) acceptability within the 
community where the facility is to 
be located; and 
(iv) the program being implemented to 
ensure concerns of the public are 
being met; and 
(4) proposed time schedules for 
construction, receipt of waste, and first 
emplacement of waste at the proposed 
land disposal facility, 
(b) The following are additional requirements 
applicable to the information required in 
Subparagraphs Parts (a)(2)(E) through (G) of this 
Rule: 

( 1 ) All information will be provided by the 
applicant with respect to the applicant 
itself, any predecessor or parent entity, 
any officer, director, partner or other 
principal of the applicant; any 
stockholder or other entity holding five 
percent or more of the stock of. or 
other interest in, the applicant; and any 
subsidiary or other entity in which the 
applicant has an interest. 

(2) All information will be be provided for 
a period of not less than 20 years or as 
may be determined by the agency with 
respect to a particular applicant or class 
of information. 

(3) With the approval of the agency, the 
applicant may submit any of the 
information, except as to the disposal of 
low-level radioactive waste, in 
summary form; provided that any 
summary must fairly and accurately 
reflect the applicant's experience and 
operating practices and must indicate 
the nature and extent of all violations of 
law and applicable regulations. 

(4) The agency may request that the 
applicant provide any supplemental 
information needed to effect the 
purpose of Subparagraphs Parts 



(a)(2)(E) through (G) of this Rule. All 
such supplementary information 
provided by or on behalf of the 
applicant will become a part of the 
application. 

Statutory Authority G.S. 104E-7; 104E- 10(b); 
104E-10.1; 104E-25; 104E-26. 

.1210 FINANCIAL FNFORMATION 

(a) The financial information shall be sufficient 
to demonstrate that the financial qualifications of 
the applicant are adequate to carry out the 
activities for which the license is sought and meet 
other financial assurance requirements of this 
Section. In addition to information required in 
Rule .1205 of this Chapter Section , the applicant 
shall provide the following financial information: 

(1) financial organization of the company; 

(2) a list of all subsidiary companies and 
their locations; 

(3) audited financial statements for the 
most recent calendar or fiscal year; 

(4) interim statements, if it has been six 
months or more since the end of the 
reporting year; 

(5) a detailed schedule of liability insurance 
coverage applicable to low-level 
radioactive waste, listing: 

(A) each insurance company's name, 

(B) amount of coverage, 

(C) any limitations on coverage, 

(D) duration of insurance policies, and 

(E) whether the company is licensed by 
the North Carolina Insurance 
Commissioner; 

(6) status and nature of any outstanding 
civil action to which the applicant is a 
party, and of any administrative or 
criminal proceeding against the 
applicant; and the same information 
with respect to any business entity 
which holds an interest of five percent 
or more in the applicant, or in which 
the applicant holds any interest; subject 
to the following provisions: 

(A) upon request by the agency, the 
information required by this 
Subparagraph shall include a copy of 
any document which is a part of 
public record in any such action or 
proceeding; 

(B) with the approval of the agency, the 
applicant may submit any of the 
information required by this 



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Subparagraph in summary form, 
provided that any summary must 
fairly and accurately reflect the scope 
and content of such information: 

(C) with the approval of the agency, the 
applicant may exclude information 
which would otherwise be required by 
this Subparagraph provided that the 
applicant identifies the types of 
information to be omitted and satisfies 
the agency that such types of 
information are not material to the 
applicant's ability to operate a facility 
under this Section: and 

(D) unless specifically requested by the 
agency, the following types of actions 
if brought in North Carolina, or 
equivalent types of actions if brought 
in any other jurisdiction, are excluded 
from the reporting requirements of 
this Subparagraph: 

(i) small claims actions as defined in 

G.S. 7A-210. 
(ii) infractions as defined in G.S. 

14-3.1. and 
(iii) misdemeanors under Chapter 20 
(Motor Vehicles) of the General 
Statutes: and 
(7) details of any other resources such as 
reserves or bonds to cover potential 
damages. 
(b) The applicant shall describe the financial 
responsibility and liability coverage for: 

(1) all injuries to public, property, workers 
and environment: 

(2) failure to operate as designed; and 

(3 ) post-closure monitoring and 
surveillance. 

(ci The information required in Paragraphs (a) 
and (b) of this Rule shall be updated annually to 
the extent that such information is not provided in 
the annual certified financial statement required in 
Rule .1238 of this Section. 

Statutory Authority G.S. 104E-7: 104E-10(b); 
W4E-10.1; 104E-25; 104E-26. 

.1215 CONDITIONS OF LICENSE 

(a) A license issued under this Section, or any 
right thereunder, may not be transferred, assigned, 
or in any manner disposed of. either voluntarily or 
involuntarily, directly or indirectly, through 
transfer of control of the license to any person, 
unless the agency finds, after securing full 
information, that the transfer is in accordance with 



the provisions of the North Carolina Radiation 
Protection Act (Act) and gives its consent in 
writing in the form of a license amendment. 

(b) At any time before termination of the 
license, the licensee shall submit written statements 
under oath upon request of the agency to enable 
the agency to determine whether or not the license 
should be modified, suspended, or revoked. 

(c) The license will be transferred to the 
custodial agency only on the full implementation of 
the final closure plan as approved by the agency, 
including postclosure observation and maintenance. 

(d) The licensee shall be subject to the 
provisions of the Act now or hereafter in effect, 
and to all rules and orders of the agency. The 
terms and conditions of the license are subject to 
amendment, revision, or modification, bv reason 
of amendments to. or by reason of rules and 
orders issued in accordance with terms of the Act. 

(e) Any license may be revoked, suspended or 
modified in whole or in part for any material false 
statement in the application or any misstatement of 
fact required under the Act. or because of 
conditions revealed by any application or statement 
of fact or any report, record, or inspection or 
other means which would warrant the agency to 
refuse to grant a license on the original 
application, or for failure to operate the facility in 
accordance with the terms of the license, or for 
any violation of. or failure to observe any of the 
terms and conditions of the Act. or any rule, 
license or order of the agency. 

(f) Each person licensed by the agency pursuant 
to the Rule s rules in this Section shall confine 
possession and use of radioactive materials to the 
locations and purposes authorized in the license. 

(g) No waste may be disposed of until the 
agency has inspected the land disposal facility and 
has found it to be in conformance with the 
description, design, and construction described in 
the application for a license. 

(h) The agency may incorporate in any license 
at the time of issuance, or thereafter, by 
appropriate rule or order, additional requirements 
and conditions with respect to the licensee's 
receipt, possession, and disposal of waste as it 
deems appropriate or necessary in order to: 

(1) protect the health and safety of the 
public and the environment. or 
minimize danger to life or property: 
and 

(2) require reports and the keeping of 
records, and to provide for inspections 
of activities under the license that may 
be necessary or appropriate to 



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effectuate the purposes of the Act and 
rules thereunder. 

(i) The agency may incorporate in any license at 
the time of issuance, or thereafter, by appropriate 
rule or order, a requirement that the licensee 
provide the agency with continuing information 
with respect to any information required as a part 
of the license application. 

(j) Except as provided otherwise by the agency 
pursuant to Paragraph (h) of this Rule and 
consistent with G.S. 104E-25(h), the licensee shall 
not accept or dispose of: 

(1) liquid waste which has not been 
solidified in a manner deemed 
acceptable by the agency; 

(2) any waste containing chelating agents in 
concentrations greater than one-tenth of 
one percent by weight unless: 

(A) the chelating agent content does not 
exceed eight percent by weight, and 

(B) the waste has been solidified and 
meets the stability requirements for 
class B and C waste as may be 
specified by the agency after 
consideration of current regulatory 
guides on waste form of the U.S. 
Nuclear Regulatory Commission, 
provided however that high integrity 
containers alone are not acceptable to 
achieve this stability requirement; and 

(3) such other waste as the agency may 
prohibit as necessary to ensure that the 
performance objectives of this Section 
will be met. 

(k) Each license will be issued for a period of 
five years from the date of issuance. The 
authority to dispose of wastes expires on the date 
stated in the license except as provided in Rule 
.1217 of this Section. 

Statutory Authority G.S. 104E-7; W4E-10(b); 
104E-12; 104E-13(a); 104E-25; 104E-26. 

.1218 CONTENTS OF APPLICATION FOR 
CLOSURE 

(a) Prior to final closure of the disposal site, or 
as otherwise directed by the agency, the applicant 
shall submit an application to amend the license 
for closure. This closure application shall include 
a final revision and specific details of the disposal 
site closure plan included as part of the license 
application submitted under Rule . 1206H-6} of this 
Section that includes each of the following: 

(1) any additional geologic, geochemical, 
hydrologic, or other data obtained 



during the operational period pertinent 
to the long-term containment of 
emplaced wastes; 

(2) the results of tests, experiments, or any 
other analyses relating to backfill of 
excavated areas, closure and sealing, 
waste migration and interaction with 
emplacement media, or any other tests, 
experiments, or analyses pertinent to 
the long-term containment of emplaced 
waste within the disposal site; 

(3) any proposed revision of plans for: 

(A) decontamination and dismantlement of 
surface facilities; 

(B) backfilling of excavated areas; or 

(C) stabilization of the disposal site for 
postclosure care; and 

(4) any significant new information 
regarding the environmental impact of 
closure activities and long-term 
performance of the disposal site. 

(b) Upon review and consideration of an 
application to amend the license for closure 
submitted in accordance with Paragraph (a) of this 
Rule, the agency may issue an amendment 
authorizing closure if there is reasonable assurance 
that the long-term performance objectives of this 
Section will be met. 

Statutory Authority G.S. 104E-7; 104E-9(3); 
104E-10; 104E-10. 1; 104E-18; 104E-25; 104E-26; 
104G-13; 104G-14. 



.1220 TRANSFER OF LICENSE 

Following closure and the period of postclosure 
observation and maintenance, the licensee may 
apply for an amendment to transfer the license to 
the custodial agency. The license shall be 
transferred when the agency finds: 

(1) that the closure of the disposal site has 
been made in conformance with the 
licensee's disposal site closure plan, as 
amended and approved as part of the 
license; 

(2) that reasonable assurance has been 
provided by the licensee that the 
performance objectives of this Section are 
met; 

(3) that any funds and necessary records for 
care will be transferred to the Long-Term 
Care Fund and the custodial agency, 
respectively; 

(4) that sufficient funds have accumulated in 
the Long-Term Care Fund to support 



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anticipated agency and custodial agency 
costs for all future observation, 
monitoring, maintenance and remedial 
actions; 

(5) that the postclosure monitoring program 
is operational for implementation by the 
custodial agency: and 

(6) that the custodial agency or the federal 
agency which will assume responsibility 
for institutional control of the disposal 
site is prepared to assume responsibility 
and ensure that the institutional 
requirements found necessary under 
Subparagraph Item (7) of Rule .1214 of 
this Section will be met. 

Statutory Authority G.S. 104E-7; 104E-10; 
W4E-10. 1: J04E-J2; 104E-16; 104E-18; 104E-25: 
104E-26: 104G-13; 104G-14. 

.1221 TERMINATION OF LICENSE 

la) Following any period of institutional control 
needed to meet the requirements found necessary 
under Rule .1214 of this Section, the custodial 
agency may apply for an amendment to terminate 
the license. 

(b) This application shall be filed, and will be 
reviewed, in accordance with the provisions of 
Rule s Rule .1211 of this Section and Paragraph (ai 
of this Rule. 

(ci A license will be terminated only when the 
agency finds: 

i 1 i that the institutional control 
requirements found necessary under 
Subparagraph Item (7i of Rule . 1214 of 
this Section have been met: and 
(2) that any additional requirements 
resulting from new information 
developed during the institutional 
control period have been met. and that 
permanent monuments or markers 
warning against intrusion have been 
installed. 

Statutory Authority G.S. 104E-7; 104E-10; 
104E-25; 104G-13; 104G-14. 

.1223 PROTECTION OF POPULATION 
FROM RELEASES OF 
RADIOACTIVITY 

i a) The design goal of the engineered barrier 
and other requirements in this Section is 
confinement of the disposed waste and contained 
radioactivity for at least the designed life of the 
required engineered barriers, with reasonable 



assurance that any release of radioactivity or 
radiation will not exceed the limits stated in 
Paragraph (b) of this Rule and will be as low as 
reasonably achievable as provided in Paragraph (c) 
of this Rule. 

(b) Land disposal facilities shall not cause 
external radiation levels or release concentrations 
of radioactive material to the general environment 
in groundwater, surface water, air. soil, plants, or 
animals that result in an annual equivalent dose to 
any member of the public, above background as 
determined in accordance with Rule .1231 of this 
Section, exceeding: 

( 1 1 25 millirems to the whole body. 

(2) 75 millirems to the thyroid, or 

(3) 25 millirems to any other organ. 

(c) In accordance with the ALARA plan 
required by Rule . 1206f454 of this Section, the 
licensee shall maintain releases of radioactivity in 
effluents to the general environment and resultant 
radiation dose to the public as low as reasonably 
achievable below the limits imposed in Paragraph 
(bi of this Rule. 



Statutory Authority G.S. 
104E-25; 104E-26. 



104E-7; 104E-10: 



Mil TECHNICAL REQUIREMENTS FOR 
LAND DISPOSAL FACILITIES 

The technical requirements for land disposal 
facilities are set forth in Rules .1228 through 
.1234 of this Section. Section. 



Statutory Authority G.S. 

104E-25: 104E-26. 



104E- 



104E-10; 



.1229 SITE DESIGN FOR LAND DISPOSAL 

(a) Shallow land burial is prohibited as provided 
in G.S. 104E-20(bi. 

(b) Site design features shall be directed toward 
long-term isolation and avoidance of the need for 
continuing active maintenance after site closure. 

ici The disposal site design and operation shall 
be compatible with the disposal site closure and 
stabilization plan and lead to disposal site closure 
that provides reasonable assurance that the 
performance objectives of this Section will be met. 

(dl The disposal site shall be designed to 
complement and improve, where appropriate, the 
ability of the disposal site*s natural characteristics 
to assure that the performance objectives of this 
Section will be met. 

(ei Covers shall be designed to minimize water 
infiltration, to direct percolating or surface water 
away from the disposed waste, and to resist 



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PROPOSED RULES 



degradation by surface geologic processes and 
biotic activity. 

(f) Surface features shall direct surface water 
drainage away from disposal units at velocities and 
gradients which will not result in erosion that will 
require ongoing active maintenance. 

(g) The disposal site shall be designed to 
minimize the contact of water with waste during 
storage, the contact of standing water with waste 
during disposal, and the contact of percolating or 
standing water with wastes after disposal. 

(h) The disposal units shall incorporate 
engineered barriers. The disposal units and 
incorporated engineered barriers shall be designed 
and constructed to meet the performance 
objectives, technical requirements and design 
criteria in G.S. 104E-25 and the following 
additional requirements: 

( 1 ) The engineered barriers shall provide 
reasonable assurance that they will 
complement, and where appropriate 
improve, the land disposal facility's 
ability to isolate the radioactive waste 
through the institutional control period; 

(2) Engineered barrier structural integrity 
shall be maintained under normal and 
abnormal conditions of operation; 

(3) Engineered barriers shall prevent 
contact between the surrounding earth 
and the waste, except for earth that may 
be used as fill material within the 
disposal unit; and 

(4) The disposal units shall be constructed 
or emplaced in a manner which will 
ensure that the bottom of the disposal 
facility is at least seven feet above the 
seasonal high water table or more if 
necessary to meet the performance 
objectives of this Section. 

(i) The licensee shall develop, operate and 
maintain the site in a manner that will not diminish 
the hydrogeological performance of the site below 
the requirements contained in the Rules rules of 
this Section. 



Statutory Authority G.S. 

I04E-25; 104E-2. 



104E-7; 104E-10; 



.1239 TESTS AT LAND DISPOSAL 
FACILITIES 

Each licensee shall perform, or permit the 
agency to perform, any tests the agency deems 
appropriate or necessary for the administration of 
the Rule s rules of this Section, including tests of: 

( 1 ) wastes and facilities used for the receipt, 



storage, handling, and disposal of wastes; 

(2) radiation detection and monitoring 
instruments; and 

(3) other equipment and devices used in 
connection with the receipt, possession, 
handling, storage, or disposal of waste. 

Statutory Authority G.S. 104E-7; 104E-10(b); 
104E-25; 104E-26. 

.1240 AGENCY INSPECTIONS OF LAND 
DISPOSAL FACILITIES 

(a) Each licensee shall afford to the agency at all 
reasonable times opportunity to inspect: 

( 1 ) waste not yet disposed of; 

(2) the premises, equipment, operations, 
and facilities in which wastes are 
received, possessed, handled, treated, 
stored or disposed of; and 

(3) records kept by the licensee pursuant to 
the applicable Rule s rules of this 
Chapter. 

(b) Authorized representatives of the agency 
may copy and take away copies of, for the 
agency's use, any record required to be kept 
pursuant to provisions of this Section. 

Statutory Authority G.S. 104E-7; 104E-10(b); 
104E-11; W4E-12; 104E-25; 104E-26. 

SECTION .1300 - REQUIREMENTS FOR 
WIRELINE-SERVICE OPERATORS AND 
SUBSURFACE-TRACER STUDIES 

.1306 TRANSPORT PRECAUTIONS 

Transport containers shall be phy s cially 
physically secured to the transporting vehicle to 
prevent accidental loss, tampering, or unauthorized 
removal. 

Statutory Authority G.S. 20-167.1; 104E-7; 
104E-10(b); 104E-15(a). 

.1308 LEAK TESTING OF SEALED 
SOURCES 

(a) Each licensee using sealed sources of 
radioactive material shall have the sources tested 
for leakage. Records of leak test results shall be 
kept in units of microcuries and maintained for 
inspection by the agency for six months after the 
next required leak test is performed or until 
transfer or disposal of the sealed source. 

(b) Tests for leakage shall be performed only by 
persons specifically authorized to perforin such 
tests by the agency, the U.S. Nuclear Regulatory 



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2140 



PROPOSED RULES 



Commission, an agreement state, or a licensing 
state. The test sample shall be taken from the 
surface of the source, source holder, or from the 
surface of the device in which the source is stored 
or mounted and on which one might expect 
contamination to accumulate. The test sample 
shall be analyzed for radioactive contamination, 
and the analysis shall be capable of detecting the 
presence of 0.005 microcurie of radioactive 
material on the test sample. 

(c) Each sealed source of radioactive material 
shall be tested at intervals not to exceed six 
months. In the absence of a certificate from a 
transferor indicating that a test has been made 
prior to the transfer, the sealed source shall not put 
into use until tested. If, for any reason, it is 
suspected that a sealed source may be leaking, it 
shall be removed from service immediately and 
tested for leakage as soon as practical. 

(d) If the test reveals the presence of 0.005 
microcurie or more of l eakeage leakage or 
contamination, the licensee shall immediately 
withdraw the source from use and shall cause it to 
be decontaminated, repaired, or disposed of in 
accordance with these Rules. A report describing 
the equipment involved, the test results, and the 
corrective action taken shall be filed with the 
agency. 

(e) The following sources are exempt from the 
periodic leak test and notification requirements of 
this Rule: 

( 1 ) hydrogen-3 sources; 

(2) sources of radioactive material with a 
half-life of 30 days or less; 

(3) sealed sources of radioactive material in 
gaseous form; 

(4) sources of beta- and/or 
gamma- emmitting emitting radioactive 
material with an activity of 100 
microcuries or less; and 

(5) sources of alpha-emitting radioactive 
material with an activity of ten 
microcuries or less. 

Statutory Authority G.S. 104E-7; 104E-12(u). 

.1309 QUARTERLY INVENTORY 

Each licensee shall conduct a quarterly physical 
inventory to account for all source - sources of 
radiation. Records of inventories shall be 
maintained for two years from the date of the 
inventory for inspection by the agency and shall 
include the quantities and kinds of sources of 
radiation, the location where sources of radiation 
are assigned, the date of the inventory, and the 



name of the individual conducting the inventory. 
Statutory Authority G.S. 104E-7; 104E-12(a)(l ). 

.1310 UTILIZATION RECORDS 

(a) Each licensee shall maintain current 
utilization records showing the following 
information for each source of radiation: 

( 1 ) make, model number, and a serial 
number or a description of each source 
of radiation used; 

(2) the identity of the well-logging 
supervisor or field unit to whom 
assigned; 

(3) locations where used and dates of use; 
and 

(4) in the case of tracer materials and 
radioactive markers, the radionuclide 
and activity used in a particular well. 

(b) The licensee shall maintain the utilization 
records, required in Paragraph (a) of this Rule, for 
inspection by the agency for a period of two years 
from the date of the recorded event(s). 

Statutory Authority G.S. 104E-7; 104E-12(a)(l). 

.1313 INSPECTION AND MAINTENANCE 

(a) Each licensee shall conduct, at intervals not 
to exceed six months, a program of inspection and 
maintenance of source holders, logging tools, 
source handling tools, storage containers, transport 
containers, and injection tools to assure proper 
labeling and proper physical condition. The 
licensee shall maintain records of inspection and 
maintenance for a period of two years for inspec- 
tion by the agency. 

(b) If any inspection conducted pursuant to 
Paragraph (a) of this Rule reveals damage to 
labeling or components critical to radiation safety, 
the licensee shall remove the device from service 
until repairs have been made. 

(c) The repair, opening, or modification of any 
sealed source shall be performed only by persons 
specifically authorized to do so by the agency, the 
U.S. Nuclear Regulatory Commission, an agree- 
ment state, or a licensing state. 

Statutory Authority G.S. 104E-7. 



1\ otice is hereby given in accordance with G.S. 
I50B-21.2 that the EHNR-Commission for Health 
Services intends to amend rides cited as 15A 



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PROPOSED RULES 



NCAC 13A .0001 - .0014 and adopt rule cited as 
15A NCAC 13A .0018. 



CHAPTER 13 - SOLID WASTE 
MANAGEMENT 



1 he proposed effective date of this action is April 
1. 1993. 

1 he public hearing will he conducted at 1:30 
p.m. on January 20. 1993 at the Highway Build- 
ing, First Floor Auditorium. 1 South Wilmington 
Street. Raleigh. North Carolina. 

iVeason for Proposed Action: To clarify and 
establish a uniform and consistent approach to the 
regulation of off-site recycling facilities; to set fees 
for permit modifications; and to comply with 
federal rules promulgated between July 10. 1992 
and September 10. 1992. which are required to 
remain in compliance with EPA authorization 
requirements. 

(comment Procedures: All persons interested in 
these matters are invited to attend the public 
hearing. Written comments may be presented at 
the public hearing or submitted to John P. 
Barkley. Department of Justice. P.O. Box 629, 
Raleigh, NC 27602-0629, (919)733-4618. If you 
desire to speak at the public hearing, notify John 
P. Barkley at least 3 days prior to the public 
hearing. Oral presentation lengths may be limited 
depending on the number of people that wish to 
speak at the public hearing. Only persons who 
have made comments at a public hearing or who 
have submitted written comments will be allowed 
to speak at the Commission meeting. Comments 
made at the Commission meeting must either 
clarify previous comments or address proposed 
changes from staff pursuant to comments made 
during the public hearing process. 

IT IS VERY IMPORTANT THAT ALL 
INTERESTED AND POTENTIALLY AFFECTED 
PERSONS, GROUPS. BUSINESSES, 
ASSOCIATIONS, INSTITUTIONS. OR AGENCIES 
MAKE THEIR VIEWS AND OPINIONS KNOWN 
TO THE COMMISSION FOR HEALTH SERVICES 
THROUGH THE PUBLIC HEARING AND 
COMMENT PROCESS, WHETHER THEY 
SUPPORT OR OPPOSE ANY OR ALL 
PROVISIONS OF THE PROPOSED R ULES. THE 
COMMISSION MAY MAKE CHANGES TO THE 
R ULES A T THE COMMISSION MEETING IF THE 
CHANGES COMPLY WITH G.S. 150B-21 .2(f). 



SUBCHAPTER 13 A - HAZARDOUS WASTE 

MANAGEMENT 

.0001 GENERAL 

(a) The Hazardous Waste Section of the Solid 
Waste Management Division shall administer the 
hazardous waste management program for the 
State of North Carolina. 

(b) In applying the federal requirements incorpo- 
rated by reference throughout this Subchapter, the 
following substitutions or exceptions shall apply: 

(1) "Department of Environment, Health, 
and Natural Resources" shall be substi- 
tuted for "Environmental Protection 
Agency" except in 40 CFR 262.51 
through 262.54, 262.56, 262.57 where 
references to the Environmental Protec- 
tion Agency shall remain without sub- 
stitution; 

(2) "Secretary of the Department of Envi- 
ronment, Health, and Natural Resourc- 
es" shall be substituted for "Administra- 
tor," "Regional Administrator" and 
"Director" except for 40 CFR 262.55 
through 262.57, 264.12(a), 268.5, 
268.6, 268.42(b) and 268.44 where the 
references to the Administrator, Re- 
gional Administrator, and Director shall 
remain without substitution; and 

(3) An "annual report" shall be required 
for all hazardous waste generators, 
treaters, storers, and disposers rather 
than a "biennial report". 

(c) In the event that there are inconsistencies or 
duplications in the requirements of those Federal 
rules incorporated by reference throughout this 
Subchapter and the State rules set out in this 
Subchapter, the provisions incorporated by refer- 
ence shall prevail except where the State rules are 
more stringent. 

<e) £dj 40 CFR 260. 1 through 260.3 (Subpart 
A), "General," have been incorporated by refer- 
ence including subsequent amendments and edi- 
tions. 

<4) fe} 40 CFR 260. 1 1 , "References", has been 
incorporated by reference including subsequent 
amendments and editions. 

fe) £Q Copies of all materials in this Subchapter 
may be inspected or obtained as follows: 

(1) Persons interested in receiving 
rule-making notices concerning the 
North Carolina Hazardous Waste 



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2142 



PROPOSED RULES 



Management Rules must submit a 
written request to the Hazardous Waste 
Section, P.O. Box 27687, Raleigh, 
N.C. 27611-7687. A check in the 
amount of fifteen dollars ($15. 00) made 
payable to The Hazardous Waste 
Section must be enclosed with each 
request. Upon receipt of each request, 
individuals will be placed on a mailing 
list to receive notices for one year. 

(2) Material incorporated by reference in 
the Federal Register may be obtained 
from the Superintendent of Documents. 
U.S. Government Printing Office, 
Washington. D.C. 20402 at a cost of 
three hundred and forty dollars 
($340.00) per year. Federal Register 
materials are codified once a year in the 
Code of Federal Regulations and may 
be obtained at the above address for a 
cost of: 40 CFR 1-51 thirty seven 
dollars ($37.00). 40 CFR 260-299 forty 
dollars ($40.00) and 40 CFR 100-149 
forty dollars ($40.00). total one 
hundred and seventeen dollars 
($117.00). 

(3) The North Carolina Hazardous Waste 
Management Rules, including the 
incorporated by reference materials, 
may be obtained from the Hazardous 
Waste Section at a cost of sixteen 
dollars ($16.00). 

(4) All material is available for inspection 
at the Department of Environment, 
Health. and Natural Resources, 
Hazardous Waste Section. 401 Oberlin 
Road. Raleigh. N.C. 

Statutory Authority G.S. 130A-294(c). 

.0002 DEFINITIONS 

(a) The definitions contained in G.S. 130A-290 
apply to this Subchapter. 

(b) 40 CFR 260. 10 (Subpart B). Definitions, has 
been adopted incorporated by reference tn 
accordance — with — G.S. — 150B 1 4 (c) . including 
subsequent amendment and editions except that 
the Definitions for "Disposal", "Landfill", 
"Management or hazardous waste management", 
"Person", "Sludge", "Storage", and "Treatment" 
are defined by G.S. 130A-290 and are not 
adopted incorporated by reference. 

(c) The following additional definitions shall 
apply throughout this Subchapter: 

(1) "Section" means the Hazardous Waste 



Section, in the Division of Solid Waste 
Management, Department of 
Environment, Health, and Natural 
Resources. 

(2) The "Department" means the N.C. 
Department of Environment, Health, 
and Natural Resources (DEHNR). 

(3) "Division" means the Solid Waste 
Management Division (SWMD). 

(4) "Long Term Storage" means the 
containment of hazardous waste for an 
indefinite period of time in a facility 
designed to be closed with the 
hazardous waste in place. 

(5) "Off-site Recycling Facility" means any 
facility that receives shipments of 
hazardous waste from off- site to be 
recycled or processed for recycling 
through any process conducted at the 
facility. 

Statutory Authority G.S. 130A-294(c). 

.0003 PETITIONS - PART 260 

(a) All rulemaking petitions for changes in this 
Subchapter shall be made in accordance with 15A 
NCAC 24B .0001. 

(b) 40 CFR 260.21 through 260.41 (Subpart C). 
"Rulemaking Petitions," have been incorporated 
adopted by reference in accordance with — G.S. 
150B 1 4 (e) including subsequent amendments and 
editions . 

Statutory Authority G.S. 130A-294(c). 

.0004 PUBLIC INFORMATION - PART 2 

(a) The provisions concerning requests for 
information in 40 CFR 2.100 to 2.120 (Subpart A) 
have been incorporated adopted by reference m 

accordance — wrth — G.S. 150B 1 4 (e) including 

subsequent amendments and editions , except that 
40 CFR 2. 100 (a) is not adopted incorpo rated by 
reference. 

(1) The following shall be substituted for 
the provisions of 40 CFR 2.100(a) 
which are not incorporated adopted by 
reference: 

(2) Definitions. 

(A) "EPA" means the United States 
Environmental Protection Agency. 

(B) "Department of Environment, Health, 
and Natural Resources" shall be 
substituted for "Environmental 
Protection Agency" and "Hazardous 
Waste Section Chief in the Solid 



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PROPOSED RULES 



Waste Management Division of the 
Department of Environment, Health, 
and Natural Resources" shall be 
substituted for "Administrator", 
"Regional Administrator" and 
"Director", except in those situations 
where authority has not been 
delegated to the State of N.C. or 
unless the context requires a different 
meaning. 

(C) "Section" means the N.C. Hazardous 
Waste Section, in the Division of 
Solid Waste Management, Department 
of Environment. Health, and Natural 
Resources. 

(D) "Section Officer" means the person 
designated by the Section Chief to this 
activity. 

(E) "Section Attorney" means the person 
designated by the Section Chief to do 
this activity. 

(F) Section Officer shall be substituted for 
the freedom of information officer. 

(G) "N.C. Hazardous Waste Section 
Public Affairs Director" shall be 
substituted for the EPA Director of 
the Office of Public Affairs. 

(H) "N.C. Hazardous Waste Section 
Office" shall be substituted for 
Regional EPA Office or/EPA Branch 
Office. 
(I) "Department" means N.C. 
Department of Environment, Health, 
and Natural Resources. 
(J) "Section Employee" shall be 

substituted for EPA Employee. 
(K) "Section Legal Office" shall be the 
Section Attorney, 
(b) The provisions concerning confidentiality of 
business information in 40 CFR 2.201 to 2.309 
(Subpart B) have been incorporated adopted by 
reference in accordance — with G.S. — I50B 1 4 (c) 
including subsequent amendments and editions , 
except that 40 CFR 2.209(b) and (c), 2.301, 
2.302, 2.303. 2.304. 2.306. 2.307. 2.308 and 
2.309 are not adopted incorporated by reference. 

Statutory Authority G.S. 130A-294(c). 

.0005 GENERAL PROGRAM 

REQUIREMENTS - PART 124 

40 CFR 124.1 through 124.21 (Subpart A). 
"General Program Requirements", have been 
incorporated adopted by reference in accordance 
wrtb — GtS: 150B 1 4 (e) including subsequent 



amendments and editions , except that 40 CFR 
124.2(c) is not incorporated adopted by reference. 

Statutory Authority G.S. 130A-294(c). 

.0006 IDENTIFICATION AND LISTING OF 
HAZARDOUS WASTES - PART 261 

(a) 40 CFR 261.1 through 261.8 (Subpart A). 
"General", have been incorporated adopted by 
reference in accordance with — G-rSr — 150B 1 4 (e) 
including subsequent amendments and editions . 

(b) 40 CFR 261. 10 through 261.11 (Subpart B), 
"Criteria for Identifying the Characteristics of 
Hazardous Waste and for Listing Hazardous 
Waste", have been incorporated adopted by 
reference in accordance — wt#i — G.S. — 150B 1 4 (c) 
including subsequent amendments and editions . 

(c) 40 CFR 261 .20 through 261 .24 (Subpart C), 
"Characteristics of Hazardous Waste" have been 
incorporated adopted by reference including 
subsequent amendments and editions in accordance 
with G.S. 150B 1 4 (e) . 

(d) 40 CFR 261. 30 through 261.35 (Subpart D). 
"Lists of Hazardous Wastes" have been 
incorporated by reference including subsequent 
amendments and editions. 

(e) The Appendices to 40 CFR Part 261 have 
been incorporated adopted by reference m 

accordance — wrth — G.S. 150B 1 4 (c) including 

subsequent amendments and editions . 

Statutory Authority G.S. 130A-294(c). 

.0007 STDS APPLICABLE TO 

GENERATORS OF HAZARDOUS 
WASTE - PART 262 

(a) 40 CFR 262. 10 through 262.12 (Subpart A), 
"General", have been incorporated adopted by 
reference in accordance — with — G.S. — 150B 1 4 (c) 
including subsequent amendments and editions . 

(b) 40 CFR 262.20 through 262.23 (Subpart 
B), "The Manifest", have been incorporated 
adopted by reference including subsequent 
amendments and editions in accordance with G.S. 
150B 1 4 (c) . 

(c) 40 CFR 262.30 through 262.34 (Subpart C). 
"Pre-Transport Requirements", have been 
incorporated adopted by reference in accordance 

wt#i — G.S. 150B 1 4 (c) including subsequent 

amendments and editions . 

(d) 40 CFR 262.40 through 262.44 (Subpart D), 
"Recordkeeping and Reporting", have been 
incorporated adopted by reference including 
subsequent amendments and editions in accordance 
with G.S. 150B 1 4 (c) . In addition, a generator 



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2144 



PROPOSED RULES 



shall keep records of inspections and results of 
inspections required by Section 262.34 for at least 
three years from the date of the inspection. 

(e) 40 CFR 262.50 through 262.58 (Subpart E). 
"Exports of Hazardous Waste", have been 
incorporated adopted by reference including 
subsequent amendments and editions in accordanc e 

with G.S. 150B 1 4 (c) . 

(f) 40 CFR 262.60 (Subpart F). "Imports of 
Hazardous Waste", has been incorporated adopted 
by reference in accordance with G.S. 150B 1 4 (c) 
including subsequent amendments and editions . 

(g) 40 CFR 262.70 (Subpart G), "Farmers" has 
been incorporated adopted by reference including 
subsequent amendments and editions in accordance 
with G.S.150B 1 4 (c) . 

(h) Fhe Appendix to 40 CFR Part 262 has been 
incorporated adopted by reference in accordance 
with — Gr-S: — 150B 1 4 (c) including subsequent 
amendments and editions : however, Items 1). 1 . 
H. and I on the form in the Appendix to 40 CFR 
Part 262 are required to be completed on the 
North Carolina Hazardous Waste Manifest form. 

Statutory Authority G.S. 130A-294(c). 

.0008 STDS APPLICABLE TO 

TRANSPORTERS OF HAZARDOUS 
WASTE - PART 263 

(a) 40 CFR 263. 10 through 263.12 (Subpart A). 
"General", have been adopted incorporated by 
reference in accordance — w+#) — G.S. — 150B 1 4 (c) 
including subsequent amendments and editions . 

(b) 40 CFR 263.20 through 263.22 (Subpart B), 
"Compliance With the Manifest System and 
Recordkeeping", have been adopted incorporated 
by reference in accordance with G.S. 150B 1 4 (c) 
including subsequent amendments and editions . 

(c) 40 CFR 263.30 through 263.31 (Subpart C). 
"Hazardous Waste Discharges", have been adopted 
incorporated by reference in accordance with G.S. 
150B 1 4 (c) including subsequent amendments and 
editions . 

Statutory Authority G.S. 130A-294(c). 

.0009 STANDARDS FOR 

OWNERS/OPERATORS OF HWTSD 
FACILITIES - PART 264 

(a) Any person who treats, stores or disposes of 
hazardous waste shall comply with the 
requirements set forth in this Section. The 
treatment, storage or disposal of hazardous waste 
is prohibited except as provided in this Section. 

(b) 40 CFR 264.1 through 264.4 (Subpart A). 



"General", have been incorporated by reference 
including subsequent amendments and editions 
addition s. 

(c) 40 CFR 264. 10 through 264. 19 (Subpart B), 
"General Facility Standards", have been 
incorporated by reference including subsequent 
amendments and editions additions . 

(d) 40 CFR 264.30 through 264.37 (Subpart C), 
"Preparedness and Prevention", have been 
incorporated by reference including subsequent 
amendments and editions additions . 

(e) 40 CFR 264.50 through 264.56 (Subpart D), 
"Contingency Plan and Emergency Procedures", 
have been incorporated by reference including 
subsequent amendments and editions addition s. 

(f) 40 CFR 264.70 through 264.77 (Subpart E). 
"Manifest System, Recordkeeping, and 
Reporting", have been incorporated by reference 
including subsequent amendments and editions 
addition s. 

(g) 40 CFR 264.90 through 264.101 (Subpart 
F), "Releases From Solid Waste Management 
Units", have been incorporated by reference 
including subsequent amendments and editions 
addition s. For the purpose of this incorporation by 
reference, "January 26, 1983" shall be substituted 
for "July 26. 1982" contained in 40 CFR 
264.90(a)(2). 

(h) 40 CFR 264.1 10 through 264.120 (Subpart 
G). "Closure and Post-Closure", have been 
incorporated by reference including subsequent 
amendments and editions addition s. 

(i) 40 CFR 264.140 through 264.151 (Subpart 
H), "Financial Requirements", have been 
incorporated by reference including subsequent 
amendments and editions additions , except that 40 
CFR 264.143(a)(3). (a)(4). (a)(5), (a)(6). 40 CFR 
264.145(a)(3), (a)(4), (a)(5), and 40 CFR 
264.151(a)(1), Section 15 are not incorporated by 
reference. 

( 1 ) The following shall be substituted for 
the provisions of 40 CFR 264.143(a)(3) 
which were not incorporated by 
reference: 

The owner or operator shall deposit the 
full amount of the closure cost estimate 
at the time the fund is established. 
Within 1 year of the effective date of 
these Rules regulations , an owner or 
operator using a closure trust fund 
established prior to the effective date of 
these Rules regulation s shall deposit an 
amount into the fund so that its value 
after this deposit at least equals the 
amount of the current closure cost 



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PROPOSED RULES 



estimate, or shall obtain other financial 
assurance as specified in this Section. 

(2) The following shall be substituted for 
the provisions of 40 CFR 264. 143(a)(6) 
which were not incorporated by 
reference: 

After the trust fund is established, 
whenever the current closure cost 
estimate changes, the owner or operator 
shall compare the new estimate with the 
trustee's most recent annual valuation 
of the trust fund. If the value of the 
fund is less than the amount of the new 
estimate, the owner or operator within 
60 days after the change in the cost 
estimate, shall either deposit an amount 
into the fund so that its value after this 
deposit at least equals the amount of the 
current closure cost estimate, or obtain 
other financial assurance as specified in 
this section to cover the difference. 

(3) The following shall be substituted for 
the provisions of 40 CFR 264.145(a)(3) 
which were not incorporated by 
reference: 

(A) Except as otherwise provided in 
Paragraph (i)(3)(B) of this Section. 
the owner or operator shall deposit 
the full amount of the post-closure 
cost estimate at the time the fund is 
established. 

(B) If the Department finds that the owner 
or operator of an inactive hazardous 
waste disposal unit cannot provide 
financial assurance for post-closure 
through any other option (e.g. surety 
bond, letter of credit, or corporate 
guarantee), a plan for annual 
payments to the trust fund over the 
term of the RCRA post-closure permit 
may be established by the Department 
as a permit condition. 

(4) The following additional requirement 
shall apply: 

The Trustee shall notify the Department 

of payment to the trust fund, by 

certified mail within ten days following 

said payment to the trust fund. The 

notice shall contain the name of the 

Grantor, the date of payment, the 

amount of payment, and the current 

value of the trust fund. 

(j) 40 CFR 264.170 through 264.178 (Subpart 

I), "Use and Management of Containers", have 

been incorporated by reference' including 



subsequent amendments and editions additions . 

(k) 40 CFR 264. 190 through 264. 199 (Subpart 
J), "Tank Systems", have been incorporated by 
reference including subsequent amendments and 
editions additions -. 

(1) The following are requirements for Surface 
Impoundments: 

(1) 40 CFR 264.220 through 264.231 
(Subpart K), "Surface Impoundments", 
have been incorporated by reference 
including subsequent amendments and 
editions additions . 

(2) The following are additional standards 
for surface impoundments: 

(A) The liner system shall consist of at 
least two liners; 

(B) Artificial liners shall be equal to or 
greater than 30 mils in thickness; 

(C) Clayey liners shall be equal to or 
greater than five feet in thickness and 
have a maximum permeability of 1 .0 
x 10-7 cm/sec; 

(D) Clayey liner soils shall have the same 
characteristics as described in 
(r)(4)(B)(ii), (iii), (iv), (vi) and (vii) 
of this Rule; 

(E) A leachate collection system shall be 
constructed between the upper liner 
and the bottom liner; 

(F) A leachate detection system shall be 
constructed below the bottom liner; 
and 

(G) Surface impoundments shall be 
constructed in such a manner to 
prevent landsliding, slippage or 
slumping. 

(m) 40 CFR 264.250 through 264.259 (Subpart 
L), "Waste Piles", have been incorporated by 
reference including subsequent amendments and 
editions addition s. 

(n) 40 CFR 264.270 through 264.283 (Subpart 
M), "Land Treatment", have been incorporated by 
reference including subsequent amendments and 
editions addition s. 

(o) 40 CFR 264.300 through 264.317 (Subpart 
N), "Landfills", have been incorporated by 
reference including subsequent amendments and 
editions addition s. 

(p) A long-term storage facility shall meet 
groundwater protection, closure and post-closure, 
and financial requirements for disposal facilities as 
specified in Paragraphs (g), (h), and (i) of this 
Rule. 

(q) 40 CFR 264.340 through 264.351 (Subpart 
O), "Incinerators", have been incorporated by 



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2146 



PROPOSED RULES 



reference including subsequent amendments and 

editions additions , 
(r) The following are additional location 

standards for facilities: 

( 1 ) In addition to the location standards set 
forth in 15A NCAC 13A .0009(c). the 
Department, in determining whether to 
issue a permit for a hazardous waste 
management facility, shall consider the 
risks posed by the proximity of the 
facility to water table levels, flood 
plains, water supplies, public water 
supply watersheds, mines, natural 
resources such as wetlands, endangered 
species habitats. parks. forests, 
wilderness areas, and historical sites, 
and population centers and shall 
consider whether provision has been 
made for adequate buffer zones. The 
Department shall also consider ground 
water travel time, soil pH. soil cation 
exchange capacity, soil composition and 
permeability, slope, climate, local land 
use. transportation factors such as 
proximity to waste generators, route, 
route safety, and method of transpor- 
tation, aesthetic factors such as the visi- 
bility, appearance, and noise level of 
the facility; potential impact on air 
quality, existence of seismic activity 
and cavernous bedrock. 
(2) The following minimum separation 
distances shall be required of all 
hazardous waste management facilities 
except that existing facilities shall be 
required to meet these minimum 
separation distances to the maximum 
extent feasible: 

(A) All hazardous waste management 
facilities shall be located at least 0.25 
miles from institutions including but 
not limited to schools, health care 
facilities and prisons, unless the 
owner or operator can demonstrate 
that no unreasonable risks shall be 
posed by the proximity of the facility. 

(B) All hazardous waste treatment and 
storage facilities shall comply with the 
following separation distances: all 
hazardous waste shall be treated and 
stored a minimum of 50 feet from the 
property line of the facility: except 
that all hazardous waste with 
ignitable. incompatible or reactive 
characteristics shall be treated and 



stored a minimum of 200 feet from 
the property line of the facility if the 
area adjacent to the facility is zoned 
for any use other than industrial or is 
not zoned. 

(C) All hazardous waste landfills, 
long-term storage facilities, land 
treatment facilities and surface 
impoundments, shall comply with the 
following separation distances: 

(i) All hazardous waste shall be 
located a minimum of 200 feet 
from the property line of the 
facility: 

(ii) Each hazardous waste landfill, 
long-term storage or surface 
impoundment facility shall be 
constructed so that the bottom of 
the facility is 10 feet or more 
above the historical high ground 
water level. The historical high 
ground water level shall be 
determined by measuring the 
seasonal high ground water levels 
and predicting the long-term 
maximum high ground water level 
from published data on similar 
North Carolina topographic 
positions, elevations, geology, and 
climate: and 

(iii) All hazardous waste shall be 
located a minimum of 1 ,000 feet 
from the zone of influence of any 
existing off-site ground water well 
used for drinking water, and 
outside the zone of influence of 
any existing or planned on-site 
drinking water well. 

(D) Hazardous waste storage and 
treatment facilities for liquid waste 
that is classified as TC toxic, toxic, or 
acutely toxic and is stored or treated 
in tanks or containers shall not be 
located: 

(i) in the recharge area of an aquifer 
which is designated as an existing 
sole drinking water source as 
defined in the Safe Drinking 
Water Act. Section .1424(e) [42 
U.S.C. 300h-3(e)] unless an 
adequate secondary containment 
system is constructed, and after 
consideration of applicable factors 
in (r)(3) of this Rule, the owner 
or operator can demonstrate no 



2147 



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January 4, 1993 



PROPOSED RULES 



unreasonable risk to public health; 

(ii) within 200 feet of surface water 

impoundments or surface water 

stream with continuous flow as 

defined by the United States 

Geological Survey; 

(iii) in an area that will allow direct 

surface or subsurface discharge to 

WS-1, WS-II or SA waters or a 

Class III Reservoir as defined in 

15A NCAC 2B .0200 and 15A 

NCAC 18C .0102; 

(iv) in an area that will allow direct 

surface or subsurface discharge to 

the watershed for a Class I or II 

Reservoir as defined in 15A 

NCAC 18C .0102; 

(v) within 200 feet horizontally of a 

100-year floodplain elevation; 
(vi) within 200 feet of a seismically 
active area as defined in (c) of 
this Rule; and 
(vii) within 200 feet of a mine, cave, 
or cavernous bedrock. 
(3) The Department may require any 
hazardous waste management facility to 
comply with greater separation 
distances or other protective measures 
necessary to avoid unreasonable risks 
posed by the proximity of the facility to 
water table levels, flood plains, water 
supplies, public water supply 
watersheds, mines, natural resources 
such as wetlands, endangered species 
habitats, parks, forests, wilderness 
areas, and historical sites, and 
population centers or to provide an 
adequate buffer zone. The Department 
may also require protective measures 
necessary to avoid unreasonable risks 
posed by the soil pH, soil cation 
exchange capacity, soil composition and 
permeability, climate, transportation 
factors such as proximity to waste 
generators, route, route safety, and 
method of transportation, aesthetic 
factors such as the visibility, 
appearance, and noise level of the 
facility, potential impact on air quality, 
and the existence of seismic activity and 
cavernous bedrock. In determining 
whether to require greater separation 
distances or other protective measures, 
the Department shall consider the 
following factors: 



(A) All proposed hazardous waste 
activities and procedures to be 
associated with the transfer, storage, 
treatment or disposal of hazardous 
waste at the facility; 

(B) The type of hazardous waste to be 
treated, stored, or disposed of at the 
facility; 

(C) The volume of waste to be treated, 
stored, or disposed of at the facility; 

(D) Land use issues including the number 
of permanent residents in proximity to 
the facility and their distance from the 
facility; 

(E) The adequacy of facility design and 
plans for containment and control of 
sudden and non-sudden accidental 
events in combination with adequate 
off-site evacuation of potentially 
adversely impacted populations; 

(F) Other land use issues including the 
number of institutional and 
commercial structures such as airports 
and schools in proximity to the 
facility, their distance from the 
facility, and the particular nature of 
the activities that take place in those 
structures; 

(G) The lateral distance and slope from 
the facility to surface water supplies 
or to watersheds draining directly into 
surface water supplies; 

(H) The vertical distance, and type of 
soils and geologic conditions 
separating the facility from the water 
table; 
(I) The direction and rate of flow of 
ground water from the sites and the 
extent and reliability of on-site and 
nearby data concerning seasonal and 
long-term groundwater level 
fluctuations; 
(J) Potential air emissions including rate, 
direction of movement, dispersion and 
exposure^ whether from planned or 
accidental, uncontrolled releases; and 
(K) Any other relevant factors. 
(4) The following are additional location 
standards for landfills, long-term 
storage facilities and hazardous waste 
surface impoundments: 
(A) A hazardous waste landfill, long-term 
storage, or a surface impoundment 
facility shall not be located: 
(i) In the recharge area of an aquifer 



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2148 



PROPOSED RULES 



which is an existing sole drinking 
water source; 

(ii) Within 200 feet of a surface water 
stream with continuous flow as 
defined by the United States 
Geological Survey; 

(iii) In an area that will allow direct 
surface or subsurface discharge to 
WS-I, WS-I1 or SA waters or 
Class III Reservoir as defined in 
15A NCAC 2B .0200 and 15A 
NCAC 18C .0102; 

(iv) In an area that will allow direct 
surface or subsurface discharge to 
a watershed for a Class I or II 
Reservoir as defined in 15A 
NCAC 18C .0102; 

(v) Within 200 feet horizontally of a 
100-year flood hazard elevation; 

(vi) Within 200 feet of a seismically 
active area as defined in (c) of 
this Rule; and 

(vii) Within 200 feet of a mine, cave 
or cavernous bedrock. 
(B) A hazardous waste landfill or 
long-term storage facility shall be 
located in highly weathered, relatively 
impermeable clayey formations with 
the following soil characteristics; 

(i) The depth of the unconsolidated 
soil materials shall be equal to or 
greater than 20 feet; 

(ii) The percentage of fine-grained 
soil material shall be equal to or 
greater than 30 percent passing 
through a number 200 sieve; 

(iii) Soil liquid limit shall be equal to 
or greater than 30; 

(iv) Soil plasticity index shall be equal 
to or greater than 15; 

(v) Soil compacted hydraulic 
conductivity shall be a maximum 
of 1.0 x id" 7 cm/sec; 

(vi) Soil Cation Exchange Capacity 
shall be equal to or greater than 5 
milliequivalents per 100 grams; 

(vii) Soil Potential Volume Change 
Index shall be equal to or less 
than 4; and 

(viii) Soils shall be underlain by a 
competent geologic formation 
having a rock quality designation 
equal to or greater than 75 
percent unless other geological 
conditions afford adequate 



protection of public health and the 

environment. 
(C) A hazardous waste landfill or 
long-term storage facility shall be 
located in areas of low to moderate 
relief to the extent necessary to 
prevent landsliding or slippage and 
slumping. The site may be graded to 
comply with this standard. 

(5) All new hazardous waste impoundments 
that close with hazardous waste residues 
left in place shall comply with the 
standards for hazardous waste landfills 
in (r)(4) of this Rule unless the 
applicant can demonstrate that 
equivalent protection of public health 
and environment is afforded by some 
other standard. 

(6) The owners and operators of all new 
hazardous waste management facilities 
shall construct and maintain a minimum 
of two observation wells. one 
upgradient and one downgradient of the 
proposed facility; and shall establish 
background groundwater concentrations 
and monitor annually for all hazardous 
wastes that the owner or operator 
proposes to store, treat, or dispose at 
the facility. 

(7) The owners and operators of all new 
hazardous waste facilities shall 
demonstrate that the community has had 
an opportunity to participate in the 
siting process by complying with the 
following: 

(A) The owners and operators shall hold 
at least one public meeting in the 
county in which the facility is to be 
located to inform the community of 
all hazardous waste management 
activities including but not limited to; 
the hazardous properties of the waste 
to be managed; the type of 
management proposed for the wastes; 
the mass and volume of the wastes; 
and the source of the wastes; and to 
allow the community to identify 
specific health. safety and 
environmental concerns or problems 
expressed by the community related to 
the hazardous waste activities 
associated with the facility. The 
owners and operators shall provide a 
public notice of this meeting at least 
30 days prior to the meeting. Public 



2149 



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January 4, 1993 



PROPOSED RULES 



notice shall be documented in the 
facility permit application. The 
owners and operators shall submit as 
part of the permit application a 
complete written transcript of the 
meeting, all written material 
submitted that represents community 
concerns, and all other relevant 
written material distributed or used at 
the meeting. The written transcript 
and other written material submitted 
or used at the meeting shall be sub- 
mitted to the local public library 
closest to and in the county of the 
proposed site with a request that the 
information be made available to the 
public. 

(B) For the purposes of this Rule, public 
notice shall include: notification of 
the boards of county commissioners 
of the county where the proposed site 
is to be located and all contiguous 
counties in North Carolina; a legal 
advertisement placed in a newspaper 
or newspapers serving those counties; 
and provision of a news release to at 
least one newspaper, one radio 
station, and one TV station serving 
these counties. Public notice shall 
include the time, place, and purpose 
of the meetings required by this Rule. 

(C) No less than 30 days after the first 
public meeting transcript is available 
at the local public library, the owners 
and operators shall hold at least one 
additional public meeting in order to 
attempt to resolve community 
concerns. The owners and operators 
shall provide public notice of this 
meeting at least 30 days prior to the 
meeting. Public notice shall be 
documented in the facility permit 
application. The owners and 
operators shall submit as part of the 
permit application a complete written 
transcript of the meeting, all written 
material submitted that represents 
community concerns, and all other 
relevant written material distributed or 
used at the meeting. 

(D) The application, written transcripts of 
all public meetings and any additional 
material submitted or used at the 
meetings, and any additions or 
corrections to the application. 



including any responses to notices of 

deficiencies shall be submitted to the 

local library closest to and in the 

county of the proposed site, with a 

request that the information be made 

available to the public until the permit 

decision is made. 

(E) The Department shall consider 

unresolved community concerns in the 

permit review process and impose 

final permit conditions based on 

sound scientific, health, safety, and 

environmental principles as authorized 

by applicable laws or rules. 

(s) 40 CFR 264.570 through 264.575 (Subpart 

W), "Drip Pads", have been incorporated by 

reference including subsequent amendments and 

editions. 

(t) 40 CFR 264.600 through 264.603 (Subpart 
X), "Miscellaneous Units", have been incorporated 
by reference including subsequent amendments and 
editions. 

(u) 40 CFR 264.1030 through 264.1049 
(Subpart AA), "Air Emission Standards for 
Process Vents", have been incorporated by 
reference including subsequent amendments and 
editions. 

(v) 40 CFR 264.1050 through 264.1079 
(Subpart BB),"Air Emission Standards for 
Equipment Leaks", have been incorporated by 
reference including subsequent amendments and 
editions. 

(w) 40 CFR 264.1100 through 264.1102 
(Subpart DP). "Containment Buildings", have 
been incorporated by reference including 
subsequent amendments and editions. 

(x) (w) Appendices to 40 CFR Part 264 have 
been incorporated by reference including 
subsequent amendments and editions. 

Statutory Authority G.S. 130A-294(c). 

.0010 INTERIM STATUS STDS FOR 
OWNERS-OP OF HWTSD 
FACILITIES - PART 265 

(a) 40 CFR 265.1 through 265.4 (Subpart A). 
"General", have been incorporated by reference 
including subsequent amendments and editions 
additions . 

(b) 40 CFR 265. 10 through 265. 19 (Subpart B). 
"General Facility Standards", have been 
incorporated by reference including subsequent 
amendments and editions addition s. 

(c) 40 CFR 265.30 through 265.37 (Subpart C), 
"Preparedness and Prevention", have been 



7:19 



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January 4, 1993 



2150 



PROPOSED RULES 



incorporated by reference including subsequent 
amendments and editions addition s. 

(d) 40 CFR 265.50 through 265.56 (Subpart D). 
"Contingency Plan and Emergency Procedures", 
have been incorporated by reference including 
subsequent amendments and editions addition s. 

(e) 40 CFR 265.70 through 265.77 (Subpart E), 
"Manifest System. Recordkeeping. and 
Reporting", have been incorporated by reference 
including subsequent amendments and editions 
additions . 

(f) 40 CFR 265.90 through 265.94 (Subpart F), 
"Ground-Water Monitoring". have been 
incorporated bv reference including subsequent 
amendments and editions additions . 

(g) 40 CFR 265.110 through 265.120 (Subpart 
G). "Closure and Post-Closure". have been 
incorporated bv reference including subsequent 
amendments and editions additions . 

ih) 40 CFR 265.140 through 265.151 (Subpart 
H). "Financial Requirements". have been 
incorporated bv reference including subsequent 
amendments and editions addition s, except that 40 
CFR 265.143(a)(3). (a)(4). (a)(5). (a)(6). and 40 
CFR 265.145(a)(3). (a)(4), (a)(5). are not 
incorporated by reference. 

( 1 ) The following shall be substituted for 
the provisions of 40 CFR 265. 143(a)(3) 
which were not incorporated by 
reference: 

The owner or operator shall deposit the 
full amount of the closure cost estimate 
at the time the fund is established. 
Within 1 year of the effective date of 
these Rules regulation s, an owner or 
operator using a closure trust fund 
established prior to the effective date of 
these Rules regulation s shall deposit an 
amount into the fund so that its value 
after this deposit at least equals the 
amount of the current closure cost 
estimate, or shall obtain other financial 
assurance as specified in this Section. 

(2) The following shall be substituted for 
the provisions of 40 CFR 265.143(a)(6) 
which were not incorporated by 
reference: 

After the trust fund is established. 
whenever the current closure cost 
estimate changes, the owner or operator 
shall compare the new estimate with the 
trustee's most recent annual valuation 
of the trust fund. If the value of the 
fund is less than the amount of the new 
estimate, the owner or operator within 



60 days after the change in the cost 
estimate, shall either deposit an amount 
into the fund so that its value after this 
deposit at least equals the amount of the 
current closure cost estimate, or obtain 
other financial assurance as specified in 
this Section to cover the difference. 
(3) The following shall be substituted for 
the provisions of 40 CFR 265.145(a)(3) 
which were not incorporated by 
reference: 

(A) Except as otherwise provided in 
Paragraph (h)(3)(B) of this Section. 
the owner or operator shall deposit 
the full amount of the post-closure 
cost estimate at the time the fund is 
established. 

(B) If the Department finds that the owner 
or operator of an inactive hazardous 
waste disposal unit cannot provide 
financial assurance for post-closure 
through any other option (e.g. surety 
bond, letter of credit, or corporate 
guarantee). a plan for annual 
payments to the trust fund during the 
interim status period may be 
established by the Department by use 
of an Administrative Order. 

(i) 40 CFR 265.170 through 265.177 (Subpart 
I). "Use and Management of Containers", have 
been incorporated by reference including 
subsequent amendments and editions addition s. 
Additionally, the owner or operator shall keep 
records and results of required inspections for at 
least three years from the date of the inspection. 

(j) 40 CFR 265.190 through 265.201 (Subpart 
J), "Tank Systems", have been incorporated by 
reference including subsequent amendments and 
editions additions . 

(k) 40 CFR 265.220 through 265.230 (Subpart 
K), "Surface Impoundments". have been 
incorporated by reference including subsequent 
amendments and editions addition s. 

(1) 40 CFR 265.250 through 265.260 (Subpart 
L). "Waste Piles", have been incorporated by 
reference including subsequent amendments and 
editions additions . 

(m) 40 CFR 265.270 through 265.282 (Subpart 
M), "Land Treatment", have been incorporated by 
reference including subsequent amendments and 
editions addition s. 

in) 40 CFR 265.300 through 265.316 (Subpart 
N). "Landfills", have been incorporated bv 
reference including subsequent amendments and 
editions addition s. 



2757 



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January 4, 1993 



PROPOSED RULES 



(o) 40 CFR 265.340 through 265.352 (Subpart 
O), "Incinerators", have been incorporated by 
reference including subsequent amendments and 
editions additions . 

(p) 40 CFR 265.370 through 265.383 (Subpart 
P), "Thermal Treatment", have been incorporated 
by reference including subsequent amendments and 
editions additions. 

(q) 40 CFR 265.400 through 265.406 (Subpart 
Q), "Chemical, Physical, and Biological 
Treatment", have been incorporated by reference 
including subsequent amendments and editions 
additions . 

(r) 40 CFR 265.440 through 265.445 (Subpart 
W), "Drip Pads", have been incorporated by 
reference including subsequent amendments and 
editions. 

(s) 40 CFR 265. 1030 through 265. 1049 (Subpart 
AA), "Air Emission Standards for Process Vents", 
have been incorporated by reference including 
subsequent amendments and editions. 

(t) 40 CFR 265. 1050 through 265. 1079 (Subpart 
BB), "Air Emission Standards for Equipment 
Leaks'^ have been incorporated by reference 
including subsequent amendments and editions. 

iu] 40 CFR 265.1100 through 265.1102 
(Subpart DP), "Containment Buildings", have 
been incorporated by reference including 
subsequent amendments and editions. 

(v) fu-) Appendices to 40 CFR Part 265 have 
been incoiporated by reference including 
subsequent amendments and editions. 

Statutory Authority G.S. 130A-294(c). 

. 00 1 1 STDS FOR THE MGMT OF SPECIFIC 
HW/TYPES HWM FACILITIES - 
PART 266 

(a) 40 CFR 266.20 through 266.23 (Subpart C), 
"Recyclable Materials Used in a Manner 
Constituting Disposal", have been adopted 
incorporated by reference in accordance with G.S. 
150B 1 4 (c) including subsequent amendments and 
editions . 

(b) 40 CFR 266.30 through 266.35 (Subpart D). 
"Hazardous Waste Burned for Energy Recovery", 
have been adopted incorporated by reference m 

accordance — with — G.S. 150B 1 4 (c) including 

subsequent amendments and editions . 

(c) 40 CFR 266.40 through 266.44 (Subpart E), 
"Used Oil Burned for Energy Recovery", have 
been adopted incorporated by reference m 

accordance — with — G^£-. 150B 1 4 (c) including 

subsequent amendments and editions . 

(d) 40 CFR 266.70 (Subpart F), "Recyclable 



Materials Utilized for Precious Metal Recovery", 
has been adopted incorporated by reference m 

accordance — with — G-rS^ 150B 1 4 (c) including 

subsequent amendments and editions . 

(e) 40 CFR 266.80 (Subpart G), "Spent 
Lead-Acid Batteries Being Reclaimed", has been 
adopted incorporated by reference in accordance 

with — GS-. 150B 1 4 (c) including subsequent 

amendments and editions . 

(f) 40 CFR 266.100 through 266.122 (Subpart 
H), "Hazardous Waste Burned in Boilers and 
Industrial Furnaces", have been adopted incorpo- 
rated by reference tn — accordance — with — G.S. 
150B 1 4 (c) including subsequent amendments and 
editions . 

(g) Appendices to 40 CFR Part 266 have been 
adopted incorporated by reference in accordance 

with — Gr-S: 150B 1 4 (c) including subsequent 

amendments and editions . 

Statutory Authority G.S. 130A-294(c). 

.0012 LAND DISPOSAL RESTRICTIONS - 
PART 268 

(a) 40 CFR 268.1 through 268.14 26 8 .13 
(Subpart A), "General", have been incorporated 
adopted by reference in aceordanee with — G.S. 
150B 1 4 (c) including subsequent amendments and 
editions . 

(b) 40 CFR 268.30 through 268.36 268.35 
(Subpart C), "Prohibitions on Land Disposal", 
have been incorporated adopted by reference 
including subsequent amendments and editions in 

accordance with G.S. 150B 1 4 (e) . 

(c) 40 CFR 268.40 through 268.46 268. 44 
(Subpart D), "Treatment Standards", have been 
incoiporated adopted by reference in accordance 

with — G.S. 150B 1 4 (c) including subsequent 

amendments and editions . 

(d) 40 CFR 268.50 (Subpart E), "Prohibitions 
on Storage", has been incorporated adopted by 
reference in accordance — with — G.S. — 150B 1 4 (c) 
including subsequent amendments and editions . 

(e) Appendices to 40 CFR Part 268 have been 
incoiporated adopted by reference in accordance 

with — G.S. 150B 1 4 (c) including subsequent 

amendments and editions . 

Statutory Authority G.S. 130A-294(c). 

.0013 THE HAZARDOUS WASTE PERMIT 
PROGRAM - PART 270 

(a) 40 CFR 270.1 through 270.6 (Subpart A), 
"General Information", have been adopted incorpo- 
rated by reference «i accordance — with — G.S. 



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2152 



PROPOSED RULES 



150B 1 4 (c) including subsequent amendments and 
editions . For the purpose of this adoption 
incorporation by reference, "January 26. 1983" 
shall be substituted for "July 26, 1982" contained 
in 40 CFR 26 4 .90(a) 270.1(c) . 

(b) 40 CFR 270. 10 through 270.29 (Subpart B). 
"Permit Application", have been adopted 
incorporated by reference t« accordance with G.S. 
150B 1 4 (c) including subsequent amendments and 
editions . 

(c) The following are additional Part B 
information requirements for all hazardous waste 
treatment, s torage or disposal facilities: 

( 1 ) Description and documentation of the 
public meetings as required in 15A 
NCAC 13A .0009 (r)(7); 

(2) A description of the hydrological and 
geological properties of the site 
including, at a minimum, flood plains, 
depth to water table, ground water 
travel time, seasonal and long-term 
groundwater level fluctuations, 
proximity to public water supply 
watersheds, consolidated rock, soil pH, 
soil cation exchange capacity, soil 
characteristics and composition and 
permeability, existence of cavernous 
bedrock and seismic activity, slope, 
mines, climate, location and withdrawal 
rates of surface water users within the 
immediate drainage basin and well 
water users within a one mile radius of 
the facility; water quality information of 
both surface and groundwater within 
1000 ft. of the facility, and a 
description of the local air quality; 

(3) A description of the facility's proximity 
to and potential impact on wetlands, 
endangered species habitats, parks, 
forests, wilderness areas, historical 
sites, mines, and air quality; 

(4) A description of local land use 
including residential. industrial, 
commercial, recreational, agricultural 
and the proximity to schools and 
airports; 

(5) A description of the proximity of the 
facility to waste generators and 
population centers; a description of the 
method of waste transportation: the 
comments of the local community and 
state transportation authority on the 
proposed route, and route safety. 
Comments should include proposed 
alternative routes and restrictions 



necessary to protect the public health; 

(6) A description of facility aesthetic 
factors including visibility, appearance, 
and noise level; and 

(7) A description of any other objective 
factors that the Department determines 
are reasonably related and relevant to 
the proper siting and operation of the 
facility. 

(d) In addition to the specific Sp e cific Part B 
information requirements Information 
Requirements for hazardous waste disposal 
facilities, owners and operators of hazardous waste 
landfills or longterm storage facilities shall provide 
the following information: 

( 1 ) Design drawings and specifications of 
the leachate collection and removal 
system; 

(2) Design drawings and specifications of 
the artificial impervious liner; 

(3) Design drawings and specifications of 
the clay or clay-like liner below the 
artificial liner, and a description of the 
permeability of the clay or clay-like 
liner; and 

(4) A description of how hazardous wastes 
will be treated prior to placement in the 
facility. 

(e) In addition to the specific Part B Information 
i n format io n requirements for s U i face 
impoundments Surface Impoundment s, owners and 
operators of surface impoundments shall provide 
the following information: 

( 1 ) Design drawings and specifications of 
the leachate collection and removal 
system; 

(2) Design drawings and specifications of 
all artificial impervious liners; 

(3) Design drawings and specifications of 
all clay or clay-like liners and a 
description of the clay or clay-like 
liner: and 

(4) Design drawings and specifications that 
show that the facility has been 
constructed in a manner that will 
prevent landsliding. slippage. or 
slumping. 

(f) 40 CFR 270.30 through 270.33 (Subpart 
C)," Permit Conditions", have been adopted 
incorporated by reference in aeeordanee with G.S. 
150B 1 4 (e) including subsequent amendments and 
editions . 

(g) 40 CFR 270.40 through 270.43 (Subpart D). 
"Changes to Permit", have been adopted 
incorporated by reference in aeeordanee with G.S. 



2153 



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PROPOSED RULES 



150B 1 4 (c) including subsequent amendments and 
editions , 

(h) 40 CFR 270.50 through 270.51 (Subpart E). 
"Expiration and Continuation of Permits", have 
been adopted incorporated by reference in 
accordance — with — G-rSr — 150B 1 4 (c) including 
subsequent amendments and editions. 

(i) 40 CFR 270.60 through 270.66 (Subpart F), 
"Special Forms of Permits", have been adopted 
incoiporated by reference in accordance with G.S. 
150B 1 4 (c) including subsequent amendments and 
editions. 

(j) 40 CFR 270.70 through 270.73 (Subpart G), 
"Interim Status", have been adopted incorporated 
by reference in accordance with G.S. — 150B 1 4 (c) 
including subsequent amendments and editions . 
For the purpose of this adoption incorporation by 
reference, "January 1, 1986" shall be substituted 
for "November 8, 1985" contained in 40 CFR 
270.73(c). 

(k) The following are additional permitting 
requirements concerning operating record of other 
facilities. 

(1) An applicant applying for a permit for 
a hazardous waste facility shall submit 
a disclosure statement to the 
Department as a part of the application 
for a permit or any time thereafter 
specified by the Department. The 
disclosure statement shall be supported 
by an affidavit attesting to the truth and 
completeness of the facts asserted in the 
statement and shall include: 

(A) A brief description of the form of the 
business (e.g. partnership, sole 
proprietorship, corporation, 
association, or other); 

(B) The name and address of any 
hazardous waste facility constructed 
or operated after October 21. 1976. 
by the applicant or any parent or 
subsidiary corporation if the applicant 
is a corporation; and 

(C) A list identifying any legal action 
taken against any facility identified in 
Part (k)(l)(B) of this Rule involving: 

(i) any administrative ruling or order 
issued by any state, federal or 
local authority relating to 
revocation of any environmental 
or waste management permit or 
license, or to a violation of any 
state or federal statute or local 
ordinance relating to waste 
management or environmental 



protection; 
(ii) any judicial determination of 
liability or conviction under any 
state or federal law or local 
ordinance relating to waste 
management or environmental 
protection; and 
(iii) any pending administrative or 
judicial proceeding of the type 
described in this Part. 
(D) The identification of each action 
described in Part (k)(l)(C) of this 
Rule shall include the name and loca- 
tion of the facility that the action 
concerns, the agency or court that 
heard or is hearing the matter, the 
title, docket or case number, and the 
status of the proceeding. 

(2) In addition to the information set forth 
in Subparagraph (k)(l)of this Rule, the 
Department may require from any 
applicant such additional information as 
it deems necessary to satisfy the re- 
quirements of G.S. 130A-295. Such 
information may include, but shall not 
be limited to: 

(A) The names, addresses, and titles of all 
officers, directors, or partners of the 
applicant and of any parent or subsid- 
iary corporation if the applicant is a 
corporation; 

(B) The name and address of any compa- 
ny in the field of hazardous waste 
management in which the applicant 
business or any of its officers, direc- 
tors, or partners, hold an equity inter- 
est and the name of the officer, direc- 
tor, or partner holding such interest; 
and 

(C) A copy of any administrative ruling 
or order and of any judicial determi- 
nation of liability or conviction de- 
scribed in Part (k)(l)(C) of this Rule, 
and a description of any pending 
administrative or judicial proceeding 
in that item. 

(3) If the Department finds that any part or 
parts of the disclosure statement is not 
necessary to satisfy the requirements of 
G.S. 130A-295, such information shall 
not be required. 

(1) An applicant for a new, or modification to an 
existing, commercial facility permit, shall provide 
a description and justification of the need for the 
facility. 



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2154 



PROPOSED RULES 



(m) Requirements for Off- site Recycling Facili- 
ties. 

j 1 ) The permit requirements of this Rule 
apply to owners and operators of 
off- site recycling facilities. 

(2) The following provisions of 40 CFR 
Part 264. as incorporated by reference. 
shall apply to owners and operators of 
off-site recycling facilities: 

(A) Subpart B - General Facility Stan- 
dards 

(B) Subpart C - Preparedness and Preven- 
tion 

(C) Subpart D z Contingency Plan and 
Emergency Procedures 

(D) Subpart E - Manifest System. Record- 
keeping and Reporting 

(E) Subpart G ; Closure and Post-closure 

(F) Subpart H ; Financial Requirements 

(G) Subpart I : Use and Management of 
Containers 

(H) Subpart J ; Tank Systems 

IT) 264.101 - Corrective Action for Solid 

Waste Management I nits. 
(J) Subpart X - Miscellaneous Units 
(K) Subpart DP : Containment Buildings 

(3) The requirements listed in Subpara- 
graph ( m ) ( 2 ) of this Rule apply to the 
entire off- site recycling facility, includ- 
ing all recycling units, staging and 
process areas, and permanent and tem- 
porary storage areas for recycled prod- 
ucts and wastes . 

(4) The following provisions of 15A 
NCAC 13A .0009 shall apply to owners 
and operators of off-site recycling 
facilities: 

(A) The substitute financial requirements 
of Rule .0009 (i)(l). (2) and (4). 

(B) The additional standards of Rule 
■ 0009 (r)(l). (2L i3L 16] and (7L 

(5) The owner or operator of an off- site 
recycling facility shall keep a written 
operating record at his facility. 

(6) The following information must be 
recorded, as it becomes available, and 
maintained [n the operating record until 
closure of the facility: 

(A) A description and the quantity of each 
hazardous waste received, and the 
method(s) and date(s) of its treatment, 
storage, or recycling at the facility. 

(B) The location of al] hazardous waste 
within the facility and the quantity at 
each location. This information must 



i£) 



include cross-references to specific 
manifest document numbers if the 
waste was accompanied by a manifest. 
A complete documentation of the fate 
of aU hazardous wastes received from 
off-site or generated on-site. This 
shall include records of the sale, 



reuse, off-site transfer, or disposal of 
all products and waste materials, 
(n) Permit Fees for Commercial Hazardous 
Waste Facilities 

( 1 ) An applicant for a permit modification 
for a commercial hazardous waste 
facility shall pay an application fee as 
follows: 

(A) Class 1 permit modification $100 

(B) Class 2 permit modification $1 .000 

(C) Class 3 permit modification $5.000 
! Note: Administrative or informational changes 
such as personnel or telephone numbers are ex- 
cluded from the fee requirement. [■ 

(2) The application fee for a new permit, 
permit renewal, or permit modification 
must accompany the application, and js 
non-refundable. The application shall 
be considered incomplete until the fee 
js paid. Checks should be made pay- 
able to: Division of Solid Waste Man- 
agement. 

Statutory Authority G. S. l30A-294(c); 130A-294. 1; 
130A-295 (a)(1), (2), (c). 

.0014 REQMNTS/AUTHORIZATION OF 

STATE HAZARDOUS WASTE PROG 
- PART 271 

40 CFR 271.17, "Sharing of information", has 
been incorporated adopted by reference in neeor 
dance with G.S. 150B 1 4 (c) including subsequent 
amendments and editions . 

Statutory Authority G.S. 130A-294(c). 

.0018 STANDARDS FOR THE 

MANAGEMENT OF USED OIL 

la] 40 CFR 279.1 (Subpart A). "Definitions", 
has been incorporated by reference including 
subsequent amendments and editions. 

lb) 40 CFR 279. 10 through 279. 12 (Subpart B), 
"Applicability", have been incoqio rated by refer- 
ence including subsequent amendments and edi- 
tions. 

(c} 40 CFR 279.20 through 279.24 (Subpart C). 
"Standards for Used Oil Generators", have been 



incorporated by reference including subsequent 



2155 



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PROPOSED RULES 



amendments and editions. 



id) 40 CFR 279.30 through 279.32 (Subpart D), 
"Standards for Used Oil Collection Centers and 



Aggregation Points", have been incorporated by 
reference including subsequent amendments and 
editions . 

ie) 40 CFR 279.40 through 279.47 (Subpart E), 
"Standards for Used Oil Transporter and Transfer 
Facilities", have been incorporated by reference 
including subsequent amendments and editions . 

if} 40 CFR 279.50 through 279.59 (Subpart F), 
"Standards for Used Oil Processors and 
Re-Refiners", have been incorporated by reference 
including subsequent amendments and editions. 

{2} 40 CFR 279.60 through 279.67 (Subpart G), 
"Standards for Used Oil Burners Who Burn 
Off-Specification Used Oil for Energy Recovery", 
have been incorporated by reference including 
subsequent amendments and editions. 

ih] 40 CFR 279.70 through 279.75 (Subpart H). 
"Standards for Used Oil Fuel Marketers", have 
been incorporated by reference including 
subsequent amendments and editions. 

ill 40 CFR 279.80 through 279.82 (Subpart 1^ 
"Standards for Use as a Dust Suppressant and 
Disposal of Used Oil" have been incorporated by 
reference including subsequent amendments and 
editions. 

Statutory Authority G.S. 130A-294(c). 



hearing. Written comments may be presented at 
the public hearing or submitted to John P. 
Barkley, Department of Justice, P. O. Box 629, 
Raleigh, NC 27602-0629, (919)733-4618. If you 
desire to speak at the public hearing, notify John 
P. Barkley at least 3 days prior to the public 
hearing. Oral presentation lengths may be limited 
depending on the number of people that wish to 
speak at the public hearing. Only persons who 
have made comments at a public hearing or who 
have submitted written comments will be allowed 
to speak at the Commission meeting. Comments 
made at the Commission meeting must either 
clarify previous comments or address proposed 
changes from staff' pursuant to comments made 
during the public hearing process. 

IT IS VERY IMPORTANT THAT .ALL 
INTERESTED AND POTENTIALLY AFFECTED 
PERSONS, GROUPS, BUSINESSES, 
ASSOCIATIONS, INSTITUTIONS, OR AGENCIES 
MAKE THEIR VIEWS AND OPINIONS KNOWN 
TO THE COMMISSION FOR HEALTH SERVICES 
THROUGH THE PUBLIC HEARING AND 
COMMENT PROCESS, WHETHER THEY 
SUPPORT OR OPPOSE ANY OR ALL 
PROVISIONS OF THE PROPOSED R ULES. THE 
COMMISSION MA Y MAKE CHANGES TO THE 
R ULES A T THE COMMISSION MEETING IF THE 
CHANGES COMPLY WITH G.S. 150B-21 .2(f). 



X >: >: >c >< v 






IVotice is hereby given in accordance with G.S. 
150B-2 1.2 that the EHNR-Commission for Health 
Services intends to amend rules cited as 15A 
NCAC 13B .01201. .1203. .1207. 

1 he proposed effective date of this action is April 
1. 1993. 

1 he public hearing will be conducted at 1:30 
p.m. on January 20, 1993 at the Highway Build- 
ing, First Floor Auditorium, 1 South Wilmington 
Street, Raleigh, North Carolina. 

MXeason for Proposed Action: To designate 
microwave treatment as suitable technology for 
treating microbiological waste. 

Lsomment Procedures: All persons interested in 
these matters are invited to attend the public 



CHAPTER 13 - SOLID WASTE 
MANAGEMENT 

SUBCHAPTER 13B - SOLID WASTE 
MANAGEMENT 

SECTION .1200 - MEDICAL WASTE 
MANAGEMENT 

.1201 DEFINITIONS 

For the purpose of the Section, the following 
definitions apply: 

(1) "Blood and body fluids" means liquid 
blood, serum, plasma, other blood 
products, emulsified human tissue, spinal 
fluids, and pleural and peritoneal fluids. 
Dialysates are not blood or body fluids 
under this definition. 

(2) "Generating facility" means any facility 
where medical waste first becomes a 
waste, including but not limited to any 
medical or dental facility, funeral home, 
laboratory, veterinary hospital and blood 
bank. 



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2156 



PROPOSED RULES 



£61 

(6) 

(?) 

(8) 



medical 

common 



G.S. 



pharmaceutical, 
and industrial 



(3) "Integrated medical facility" means one 
or more health service facilities as 
defined in NCGS G.S. 1 3 1 E- 1 76(9b) that 
are: 

(a) located in a single county or two 
contiguous counties; 

(b) affiliated with a university 
school or that are under 
ownership and control; and 

(c) serve a single service area. 

(4) "Medical waste" as defined 
130 A 290.1 8 130A-290(18) . 

(5) "Microbiological waste" means cultures 
and stocks of infectious agents, including 
but not limited to specimens from 
medical, pathological, 
research, commercial 
laboratories. 

"Microwave treatment" means treatment 
by microwave energy for sufficient time 
to render waste non-infectious. 

(7) "Off-site" means any site which is 
not "on-site". 

(8) "On-site" means the same or 
geographically contiguous property which 
may be divided by public or private 
right-of-way. 

(9) "Pathological waste" means human 
tissues, organs and body parts; and the 
carcasses and body parts of all animals 
that were known to have been exposed to 
pathogens that are potentially dangerous 
to humans during research, were used in 
the production of biologicals or in vivo 
testing of pharmaceuticals, or that died 
with a known or suspected disease 
transmissible to humans. 

f9-> ( 10) "Regulated Medical Waste" means 
blood and body fluids in individual 
containers in volumes greater than 20 ml, 
microbiological waste, and pathological 
waste that have not been treated pursuant 
to Rule .1207 of this Section. 

f+O-) (11) "Sharps" means and includes 
needles, syringes with attached needles, 
capillary tubes, slides and cover slips, 
and scalpel blades. 

f+4-» ( 12) "Treatment" as defined in G.S. 
1 30A-309. 26(a)(2). 

Statutory Authority G.S. 130A-309.26. 

.1203 GENERAL REQUIREMENTS FOR 
REGULATED MEDICAL WASTE 

(a) Regulated medical waste shall be treated 



prior to disposal. Acceptable methods of treatment 
are as follows: 

(1) blood and body fluids in individual 
containers in volumes greater than 20 
ml - Incineration or sanitary sewage 
systems, provided the sewage treatment 
authority is notified; 

(2) microbiological waste - Incineration, 
steam sterilization, microwave 
treatment, or chemical treatment; 

(3) pathological wastes - Incineration. 

(b) Other methods of treatment shall require 
approval by the Division. 

(c) Regulated medical waste treated in 
accordance with Paragraph (a) of this Rule may be 
managed in accordance with 15A NCAC 13B 
.0100 - .0700. 

(d) Crematoriums are not subject to the 
requirements of Rule .1207(3) of this Section. 

(e) A person who treats Regulated medical waste 
at the generating facility or within an integrated 
medical facility is not subject to the storage and 
record keeping requirements of Rule .1207(1) of 
this Section. 

(f) Generating facilities and integrated medical 
facilities in operation on October 1, 1990 that 
incinerate Regulated medical waste are not subject 
to the requirements of Rule . 1207(3)(a-l) of this 
Section until January 1, 1995. 

Statutory Authority G.S. 1 30 A- 309. 26. 

.1207 OPERATIONAL REQ/REGULATED 
MEDICAL WASTE TREATMENT 
FACILITIES 

A person who treats Regulated medical waste 
shall meet the following requirements for each 
type of treatment in addition to the requirements in 
Rule .1203 of this Section. 

( I ) General requirements: 

(a) Refrigeration at an ambient temperature 
between 35 and 45 degrees Fahrenheit 
shall be maintained for Regulated 
medical waste not treated within seven 
calendar days after shipment. 

(b) Regulated medical waste shall be stored 
prior to treatment for no more than 
seven calendar days after receipt. 

(c) Regulated medical waste shall be stored 
no longer than seven calendar days 
after treatment. 

(d) Only authorized personnel shall have 
access to areas used to store Regulated 
medical waste. 

(e) All areas used to store Regulated 



2157 



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PROPOSED RULES 



medical waste shall be kept clean. 
Neither carpets nor floor coverings with 
seams shall be used in storage areas. 
Vermin and insects shall be controlled. 

(f) Prior to treatment, all Regulated 
medical waste shall be confined to the 
storage area. 

(g) All floor drains shall discharge directly 
to an approved sanitary sewage system. 
Ventilation shall be provided and shall 
discharge so as not to create nuisance 
odors. 

(h) A plan shall be prepared, maintained 
and updated as necessary to ensure 
continued proper management of 
Regulated medical waste at the facility, 
(i) Records of Regulated medical waste 

shall be maintained for each shipment 
and shall include the information listed 
in this Paragraph. This information 
shall be maintained at the treatment 
facility for no less than three years. 
(i) name and address of generator; 
(ii) date received: 

(iii) amount of waste received by number 
of packages (piece count) from each 
generator; 
(iv) date treated; 

(v) name and address of ultimate disposal 
facility, 
(j) Regulated medical waste treatment 

facilities that treat waste generated 
off-site shall submit to the Division an 
annual report, by March 1 of each year 
that summarizes the information 
collected under Subparagraph Sub-Item 
(1) (i) of this Rule for the previous 
calendar year. The report shall be 
submitted on a form prescribed and 
approved by the Division. 
(2) Steam sterilization requirements; 

(a) Steam under pressure shall be provided 
to maintain a minimum temperature of 
250 degrees Fahrenheit for 45 minutes 
at 15 pounds per square inch of gauge 
pressure during each cycle: or other 
combinations of parameters that are 
shown to effectively treat the waste. 

(b) The steam sterilization unit shall be 
provided with a chart recorder which 
accurately records time and temperature 
of each cycle. 

(c) The steam sterilization unit shall be 
provided with a gauge which indicates 
the pressure of each cycle. 



fd) Monitoring under conditions of full 
loading for effectiveness of treatment 
shall be performed no less than once 
per week through the use of biological 
indicators or other methods approved 
by the Division. 

(e) Regulated medical waste may be 
disposed of until or unless monitoring 
as required in Subparagraph Sub-Item 
(2)(d) of this Rule does not confirm 
effectiveness. 

(f) A log of each test of effectiveness of 
treatment performed shall be maintained 
and shall include the type of indicator 
used, date, time, and result of test. 

(3) Incineration requirements: 

(a) Regulated medical waste shall be 
subjected to a burn temperature in the 
primary chamber of not less than 1200 
degrees Fahrenheit. 

(b) Automatic auxiliary burners which are 
capable, excluding the heat content of 
the wastes, of independently 
maintaining the secondary chamber 
temperature at the minimum of 1800 
degrees Fahrenheit shall be provided. 
Interlocks or other process control 
devices shall be provided to prevent the 
introduction of waste material to the 
primary chamber until the secondary 
chamber achieves operating 
temperature. 

(c) Gases generated by the combustion 
shall be subjected to a minimum 
temperature of 1 800 degrees Fahrenheit 
for a period of not less than one 
second. 

(d) Continuous monitoring and recording of 
primary and secondary chamber 
temperatures shall be performed. 
Monitoring data shall be maintained for 
a period of three years. 

(e) An Air Quality Permit shall be obtained 
from the Division of Environmental 
Management prior to construction and 
operation. 

(f) A plan of procedures for obtaining 
representative weekly and monthly 
composite ash samples shall be 
submitted for Division approval prior to 
system start-up and operation. If 
design or operation of the system is 
substantially changed or modified, or if 
the waste composition, loading rate or 
loading method are substantially 



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2158 



PROPOSED RULES 



changed, the ash sampling plan will be 
subject to modification to accommodate 
such changes. Ash sampling 

procedures shall be initiated at the time 
the incineration system is first started 
for normal operation. 

(g) As a minimum, a representative sample 
of about one kilogram (2.2 lb) shall be 
collected once for every eight hours of 
operation of a continuously fed 
incinerator; once for every 24 hours of 
operation of an intermittently operated 
incinerator; or once for every batch of 
a batch loaded incinerator. The 
samples shall be collected from either 
the discharge of the ash conveyor or 
from the ash collection containers prior 
to disposal. Samples shall be 

composited in a closed container 
weekly and shall be thoroughly mixed 
and reduced to a representative sample. 
These shall be composited into monthly 
samples. For the first three months of 
operation, each monthly sample shall be 
analyzed. 

(h) For the remainder of the first year of 
operation. representative monthly 
samples shall be composited into a 
quarterly sample and analyzed at the 
end of each quarter. 

(i) After the first year, representative 

samples shall be analyzed at least twice 
a year. 

(j) Ash samples shall be tested in 

accordance with provisions of 15A 
NCAC 13B .0103(e) and submitted to 
the N.C. Solid Waste Section. 

(k) A log shall be kept documenting ash 
sampling, which shall include the date 
and time of each sample collected; the 
date. time, and identification number of 
each composite sample; and the results 
of the analyses, including laboratory 
identification. 

(1) Records of stack testing as prescribed 

in the Air Quality Permit shall be 
maintained at the facility. 

(m) Existing generating facilities shall 
conduct one weekly representative ash 
sampling and testing in accordance with 
Subparagraphs Sub-Items (3)(f), (g) and 
(j) of this Rule annually during the 
second quarter of each calendar vear. 
1 4) Chemical treatment requirements: 

(a) Cultures of throat, urine, sputum, skin 



and genitourinal tract which contain 
only the following organisms; N. 
gonorrhea, E. coli. staphylococcus, 
proteus. Candida albicans, and B. 
cereus or normal flora in individual 
plates or tubes containing 5-20 ml 
media shall be covered, for a minimum 
of one hour, with a 1 :5 dilution of 
household bleach (5.25 percent sodium 
hypochlorite) in water. The solution 
shall remain on the treated plates which 
are to be stacked in a plastic bag prior 
to disposal. The bag is to be sealed to 
prevent leakage. 

(b) Approval for other types of chemical 
treatment must be obtained from the 
Division. Request for appro val must be 
substantiated by results of demonstrated 
effectiveness of the chemical to treat the 
specific microbiological agent(s) of 
concern for the waste disposed. 
Consideration must be given to such 
factors as temperature, time of contact. 
pH. concentration and the presence and 
state of dispersion, penetrability and 
reactivity of organic material at the site 
of application. 

(c) A written plan must be maintained at 
the facility and units of the facility as 
necessary to ensure consistent 
procedures are used to treat the waste. 

(5) Micro wave treatment requirements: 

(a) Microwave energy of appropriate 
output frequency shall be provided such 
that a minimum temperature of 95 
degrees Centigrade (203 degrees 
Fahrenheit) is maintained for a 
minimum of 30 minutes each cycle; or 
other combinations of parameters that 
are shown to effectively treat the waste. 

(b) The microwave system shall be 
provided with a means to continually 
monitor and record time and 
temperature of each cycle. 

(c) Monitoring under conditions of full 
loading for effectiveness of treatment 
shall be performed through the use of a 
biological indicator or other methods 
approved by the Division. Testing shall 
be performed no less than once per 
week or as specified by the Division. 
Additional testing shall be performed if 
temperature time monitoring indicates a 
variation from requirements in Sub-Item 
(5)(a) of this Rule. 



2159 



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PROPOSED RULES 



(d) A log, of each test of effectiveness of 
treatment performed shall be maintained 
and shall include the type of indicator 
used, date, time, and result of test. 

(e) Regulated medical waste may be 
disposed of until or unless monitoring 
as required in Sub-Item (5)(c) of this 
Rule does not confirm effectiveness. 

Statutory- Authority G.S. 130A-309.26. 

I\ otice is hereby given in accordance with G.S. 
150B-21.2that the EHNR - Commission for Health 
Services intends to adopt rule cited as 15A NCAC 
18A .1969 and amend rules cited as 15A NCAC 
ISA .1948. .1956- .1957. 

1 he proposed effective date of this action is April 
1. 1993. 

1 he public hearing will be conducted at 1:30 
p.m. on January 20. 1993 at the Highway Build- 
ing, First Floor Auditorium. 1 South Wilmington 
Street. Raleigh, North Carolina. 

Lveason for Proposed Actions: 

15 A NCAC 18A .1948 - To provide clarifications 
related to the reclassification of sites for the use of 
conventional, modified, or alternative ground 
absorption sewage treatment and disposal systems 
specified in the rules. This Paragraph is being 
moved from Rule . 1957(c) since it deals with sites 
not alternative systems. 

I5A NCAC 18A .1956 - To provide correct rule 
reference in light of moving Rule . 1957(c) to 
. 1948(d). To provide for the approval of experi- 
mental or innovative nitrification trenches or lines 
under the provisions of Rule . 1969. 

15A NCAC 18A .1957 - To provide correct rule 
reference in light of moving Rule .1957(c) to 
.1948(c). To move Paragraph (c) to Rule .1948 
for consistency of rule structure and clarity. 

15A NCAC 18A .1969 - To meet the requirements 
of G.S. 130A-343 requiring the establishment of a 
uniform and systematic procedure for the applica- 
tion, review, permitting, testing, and approval of 



experimental and innovative wastewater systems. 

Lsomment Procedures: All persons interested in 
these matters are invited to attend the public 
hearing. Written comments may be presented at 
the public hearing or submitted to John P. 
Barkley, Department of Justice, P. O. Box 629, 
Raleigh, NC 27602-0629, (919)733-4618. If you 
desire to speak at the public hearing, notify John 
P. Barkley at least 3 days prior to the public 
hearing. Oral presentation lengths may be limited 
depending on the number of people that wish to 
speak at the public hearing. Only persons who 
have made comments at a public hearing or who 
have submitted written comments will be allowed 
to speak at the Commission meeting. Comments 
made at the Commission meeting must either 
clarify previous comments or address proposed 
changes from staff pursuant to comments made 
during the public hearing process. 

IT IS VERY IMPORTANT THAT ALL INTERESTED 
AND POTENTIALLY AFFECTED PERSONS, GROUPS, 
BUSINESSES, ASSOCIATIONS, INSTITUTIONS, OR 
AGENCIES MAKE THEIR VIEWS AND OPINIONS 
KNOWN TO THE COMMISSION FOR HEALTH 
SERVICES THROUGH THE PUBLIC HEARING AND 
COMMENT PROCESS, WHETHER THEY SUPPORT 
OR OPPOSE ANY OR ALL PROVISIONS OF THE 
PROPOSED RULES. THE COMMISSION MA Y MAKE 
CHANGES TO THE RULES AT THE COMMISSION 
MEETING IF THE CHANGES COMPLY WITH G.S. 
150B-2 1.2(f). 

CHAPTER 18 
ENVIRONMENTAL HEALTH 

SUBCHAPTER 18 A - SANITATION 

SECTION .1900 - SEWAGE TREATMENT 
AND DISPOSAL SYSTEMS 

.1948 SITE CLASSIFICATION 

(a) Sites classified as SUITABLE may be 
utilized for a ground absorption sewage treatment 
and disposal system consistent with these Rules. 
A suitable classification generally indicates soil 
and site conditions favorable for the operation of 
a ground absoiption sewage treatment and disposal 
system or have slight limitations that are readily 
overcome by proper design and installation. 

(b) Sites classified as PROVISIONALLY 
SUITABLE may be utilized for a ground 
absorption sewage treatment and disposal system 
consistent with these Rules but have moderate 



7:19 



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January 4, 1993 



2160 



PROPOSED RULES 



limitations. Sites classified Provisionally Suitable 
require some modifications and careful planning, 
design, and installation in order for a ground 
absorption sewage treatment and disposal system to 
function satisfactorily. 

(c) Sites classified UNSUITABLE have severe 
limitations for the installation and use of a 
properly functioning ground absorption sewage 
treatment and disposal system. An improvement 
permit shall not be issued for a site which is 
classified as UNSUITABLE. However, where a 
site is UNSUITABLE, it may be reclassified 
PROVISIONALLY SUITABLE if a special 
investigation indicates that a modified or 
alternative system can be installed in accordance 
with Rules .1956 or .1957 of this Section. 

(d) A site classified as UNSUITABLE may be 
used for a ground absorption sewage treatment and 
disposal system specifically identified in Rules 
. 1955, .1956, or .1957 of this Section or a system 
approved under Rule . 1969 if written 
documentation. including engineering, 
hydrogeologic, geologic or soil studies, indicates 
to the local health department that the proposed 
system can reasonably be expected to function 
satisfactorily. Such sites shall be reclassified as 
PROVISIONALLY SUITABLE if the local health 
department determines that the adequate 
substantiating data indicate that: 

( 1 ) a ground absorption system can be 
installed so that the effluent will receive 
adequate treatment; 

(2) the effluent will not contaminate 
groundwater or surface water; and 

(3) the effluent will not be exposed on the 
ground surface or be discharged to 
surface waters where it could come in 
contact with people, animals, or 
vectors. 

The State shall review the substantiating data if 
re quested by the local health department. 

Statutory- Authority G. S. 130A-335fc). 



.1956 MODIFICATIONS TO SEPTIC TANK SYSTEMS 

The following are modifications to septic tank systems which may be utilized to overcome selected soil and 

site limitations. Except as required in this Rule, the provisions for design and installation of Rule . 1955 of 

this Section shall apply: 

( 1 ) Sites classified UNSUITABLE as to soil depth or soil wetness may be reclassified as 

PROVISIONALLY SUITABLE with respect to soil depth or soil wetness conditions by utilizing 

shallow placement of nitrification trenches in the naturally occurring soil. Shallow trenches may be 

used where at least 24 inches of naturally occurring soil are present above saprolite, rock, or soil 

wetness conditions and all other factors are PROVISIONALLY SUITABLE or SUITABLE. Shallow 

trenches shall be designed and constructed to meet the vertical separation requirements in Rule 



2161 7:19 NORTH CAROLINA REGISTER January 4, 1993 



PROPOSED RULES 



. 1955(m) of this Section . The long-term acceptance rate shall be based on the most hydraulically 
limiting naturally occurring soil horizon within 24 inches of the ground surface or to a depth of one 
foot below the trench bottom, whichever is deeper. Soil cover above the original grade shall be 
placed at a uniform depth over the entire nitrification field and shall extend laterally five feet beyond 
the nitrification trench. The soil cover shall be placed over a nitrification field only after proper 
preparation of the original ground surface. The type and placement of soil cover shall be approved 
by the local health department. 

(2) Sites classified UNSUITABLE as to soil wetness conditions or restrictive horizons may be 
reclassified PROVISIONALLY SUITABLE as to soil wetness conditions or restrictive horizons 
when: 

(a) Soils are Soil Groups I or II with SUITABLE structure, and clay mineralogy; 

(b) Restrictive horizons, if present, are less than three inches thick or less than 12 inches from the soil 
surface; 

(c) Modifications can be made to meet the requirements in Rule .1955(m) of this Section for the 
separation between the water table and the bottom of the nitrification trench at all times and when 
provisions are made for maintenance of the drainage systems; 

(d) Easements are recorded and have adequate width for egress and ingress for maintenance of 
drainage systems serving two or more lots; 

(e) Maintenance of the drainage system is made a condition of any permit issued for the use or 
operation of a sanitary sewage system; and 

(f) Drainage may be used in other types of soil when the requirements of Rule . 1957(c) . 1948(d) in 
this Section are met. 

(3) Modified nitrification trenches or lines, including large diameter pipe (greater than four inches I.D.), 
and specially designed porous block systems may be permitted by the local health department. 

(a) Gravelless nitrification trench systems may be substituted for conventional trench systems on any 

site found to be suitable or provisionally suitable in accordance with Rules . 1940 to . 1948 of this 

Section to eliminate the need for gravel, minimize site disturbance, or for other site planning 

considerations. Gravelless nitrification trench systems shall not be used, however, where wastes 

contain high amounts of grease and oil, such as restaurants. 

(i) Large diameter pipe systems shall consist of eight-inch or ten-inch (inside diameter), corrugated. 

polyethylene tubing encased in a nylon, polyester, or nylon/polyester blend filter wrap installed 

in a nitrification trench, 12 or more inches wide and backfilled with soil classified as soil group 

I, II, or III. Nitrification area requirement shall be determined in accordance with Rules . 1955(b) 

and .1955(c), or in Rule . 1956(6)(b). Table III of this Section, when applicable, with eight-inch 

tubing considered equivalent to a two-foot-wide conventional trench and ten-inch tubing 

considered equivalent to a two and one-half-foot-wide conventional trench. The long-term 

acceptance rate shall not exceed 0.8 gallons per day per square foot. Tubing and fittings shall 

comply with the requirements of ASTM F-667. which has been adopted by reference in 

accordance with G.S. — I50B 1 4 (c). which is hereby incorporated by reference including any 

subsequent amendments and editions . Copies of the standards may be inspected in and copies 

obtained from the Division of Environmental Health, P.O. Box 27687, Raleigh. NC 2761 1-7687 

at no cost . The corrugated tubing shall have two rows of holes, each hole between three-eighths 

and one-half-inch in diameter, located 120 degrees apart along the bottom half of the pipe (each 

60 degrees from the bottom center line) and staggered so that one hole is present in the valley 

of each corrugation. The tubing shall be marked with a visible top location indicator. 120 

degrees away from each row of holes. 

Filter wrap shall be spun, bonded, or spunlaced nylon, polyester, or nylon/polyester blend nylon 
filter wrap meeting the following minimum requirements; 

Unit Weight :Oz/yd 2 = 1.0 

Sheet Grab Tensile:MD - 23 lbs. 

Trapezoid Tear:MG MP - 6.2 lbs. 



7:19 NORTH CAROLINA REGISTER January 4, 1993 2162 



PROPOSED RULES 



XD - 5.1 lbs. 

Mullen Burst:PSI = 40 

KPa = 276 

Frazier Air Perm. CFM/ft @ 0.5 "H : 0: 500^ 

Corrugated Tubing shall be covered with filter wrap at the factor)' and each joint shall be 
immediately encased in a black polyethylene sleeve which shall continue to encase the large 
diameter pipe and wrap until just prior to installation in the trench. Large diameter pipe systems 
shall be installed in accordance with this Rule and the manufacturer's guidelines. The trench 
bottom and pipe shall be level (with a maximum fall of one inch in 100 feet). Filter wrap 
encasing the tubing shall not be exposed to sunlight (ultraviolet radiation) for extended periods. 
Rocks and large soil clumps shall be removed from backfill material prior to being used. Clayey 
soils (soil group IV) shall not be used for backfill. The near end of the large diameter pipe shall 
have an eight-inch by four-inch offset adaptor (small end opening at top) suitable for receiving 
the pipe from the septic tank or distribution device and making a mechanical joint in the 
nitrification trench, 
(ii) A Prefabricated. Permeable Block Panel System (PPBPS). utilizing both horizontal and vertical 
air chambers and special construction to promote downline and horizontal distribution of effluent, 
may be used under the following conditions: 

(A) the soil and site criteria of this Section shall be met; 

(B) in calculating the required linear footage for a PPBPS's nitrification field, the linear footage 
for the nitrification line as determined in Rule .1955 (b) and (c). or in Rule .1956 (6)(b). 
Table III of this Section when applicable, shall be multiplied by 0.5 for a 16 inch PPBPS; 

(C) installation of the PPBPS shall be in accordance with these Rules except: 

(I) the PPBPS trench shall be located not less than eight feet on centers: 

(II) the installation shall be in accordance with the manufacturer's specifications; and 

(III) the sidewalls of nitrification trenches placed in Group IVa soils shall be raked to open 
pores which were damaged or sealed during excavation; 

(D) where design sewage flow is more than 480 gallons per day. the system shall be 
pressure-dosed; and 

(E) the long-term acceptance rate shall not exceed 0.8 gallons per day per square foot. 

(b) Other types of nitrification trenches or lines may be approved by the local health department on 
a site-specific basis provided s ub s tantiating data in accordance with Rule . 1957(c) . 1969 of this 
Section, arc s ubmitted which indicate that the propoi - ed nitrification trench or line will perform 
equal to or better than a conventional trench or line. 

(4) Sites classified as UNSUITABLE as to soil wetness conditions because of the presence of lateral 
water movement may be reclassified PROVISIONALLY SUITABLE as to soil wetness conditions 
when such water is intercepted and diverted to prevent saturation of the soil absorption system. 

(5) Stable slopes greater than 30 percent may be reclassified as PROVISIONALLY SUITABLE when: 

(a) The soil characteristics can be classified as SUITABLE or PROVISIONALLY SUITABLE to a 
depth of at least one foot below the bottom of the nitrification trench at the upslope side of the 
trench: 

(b) Surface water runoff is diverted around the nitrification field if necessary to prevent scouring or 
erosion of the soil over the field; and 

(c) The finished grade over the nitrification field site is returned to the original topography and 
adequately seeded, unless otherwise specified by the local health department. 

(6) Sites classified UNSUITABLE as to soil depth, with saprolite present, may be reclassified 
PROVISIONALLY SUITABLE as to soil depth when the provisions of this Paragraph are met. 

(a) An investigation of the site using pits or trenches at locations and to depths specified by the local 
health department shall be conducted. The following physical properties and characteristics must 
be present: 
ii) the saprolite shall be weathered from acidic i granite, gneiss, or schist) parent rock types of 



2163 7:19 NORTH CAROLINA REGISTER January 4, 1993 



PROPOSED RULES 



metamorphic or igneous origin; 
(ii) the saprolite texture shall be suitable and saprolite shall have less than 20 percent clay; 
(iii) clay mineralogy shall be suitable; 
(iv) the saprolite consistence shall be loose, friable to very friable when moist as determined in place 

and nonsticky or nonplastic when wet; 
(v) the saprolite shall be overlain by at least one foot of SUITABLE or PROVISIONALLY 

SUITABLE naturally occurring soil; and 
(vi) the saprolite shall have no continuous joints or fractures relic of parent rock to a depth of two feet 

below the proposed trench bottom. 

(b) Table III shall be used in determining the long-term acceptance rate for septic tank systems installed 
pursuant to Paragraph (6) of this Rule. The long-term acceptance rate shall be based on the most 
hydraulically limiting, naturally occurring saprolite to a depth of two feet below trench bottom. 

TABLE III 

SAPROLITE SAPROLITE LONG-TERM 

GROUP TEXTURAL CLASSES ACCEPTANCE RATE 

gpd/ft 2 

I Sands Sand 0.6 - 0.5 

Loamy Sand 0.5-0.4 

II Coarse Loams Sandy Loam 0.4 - 0.3 

(with lessLoam 0.3 - 0.1 
than 20% clay) 

If a low pressure pipe system is used, the long term acceptance rate in Table III shall be reduced 
by one-half and the system shall be designed in accordance with Rule .1957(a) of this Section, 
except that Rule .1957 (a)(2)(B) and Rule .1957(a)(3) shall not apply. Saprolite textural 
classifications shall be determined from disturbed materials and determined by Rule . 1941(a)(1) of 
this Section . The local health department may require low-pressure distribution in conventional 
nitrification trenches, or other modifications available under this Rule, to insure adequate effluent 
treatment and disposal. 

(c) Only ground absorption systems with a design daily flow of 480 gallons or less shall be installed 
on sites reclassified pursuant to this Paragraph [Rule .1956(6)]. 

(d) The nitrification field shall be constructed using nitrification trenches with a maximum width of 
three feet and a maximum depth of two feet on the downslope side of the nitrification trench. The 
bottom of a nitrification trench shall be a minimum of two feet above rock or saprolite that does 
not meet the requirements of Subparagraph (6)(a) of this Rule. However, where SUITABLE or 
PROVISIONALLY SUITABLE soil underlies the trench bottom, this separation distance may be 
reduced by subtracting the actual soil depth beneath the trench bottom from 24 inches to establish 
the minimum separation distance from the trench bottom to rock. 

(e) The bottom of any nitrification trench shall be a minimum of two feet above any wetness condition. 

(f) Surface and subsurface interceptor drains may be required. 

(g) Exceptions to the provisions of Rule . 1950(a) found in Rule . 1950 and .1951 of this Section shall 
not apply to systems installed pursuant to this Paragraph [Rule .1956(6)]. 

Statutory Authority G.S. 130A-335(e) and (f). 

.1957 DESIGN CRITERIA FOR DESIGN OF ALTERNATIVE SEWAGE SYSTEMS 

(a) LOW-PRESSURE PIPE SYSTEMS: Low-pressure pipe (LPP) systems with a two to five-foot pressure 
head may be utilized on sites which are SUITABLE or PROVISIONALLY SUITABLE for conventional or 
modified systems and on sites where soil and site conditions prohibit the installation of a conventional or 
modified septic tank system if the requirements of this Paragraph are met. 
(1) The LPP system shall consist of the following basic components: 

(A) a network of small-diameter (one to two inches) perforated PVC 160 psi pipe or equivalent placed 



7:19 NORTH CAROLINA REGISTER January 4, 1993 2164 



PROPOSED RULES 



in naturally occurring soil at shallow depths (generally 12 to 18 inches) in narrow trenches not 
less than eight inches in width and spaced not less than five feet on center. Trenches shall 
include at least five inches of washed stone or washed gravel below the pipe and two inches 
above the pipe; and four inches of soil cover. 

(B) a properly designed, two-compartment septic tank or other approved pretreatment system, and 
a pumping or dosing tank; 

(C) a watertight supply manifold pipe, of Schedule 40 PVC or equivalent, for conveying effluent from 
the dosing chamber to the low-pressure network. 

(2) The soil and site criteria for LPP systems shall meet the following minimum requirements: 

(A) LPP nitrification fields shall not be installed on slopes in excess often percent unless special 
design procedures to assure proper distribution of effluent over the nitrification field are 
approved. Landscaping of the LPP distribution field shall be constructed to shed rainwater or 
runoff. All other requirements of Rule .1940 of this Section shall be met. 

(B) Site suitability for an LPP system shall be based on the first 24 inches of soil beneath the 
naturally occurring soil surface. This 24 inches shall consist of SUITABLE or 
PROVISIONALLY SUITABLE soil as determined in accordance with Rules .1941 through .1944 
and . 1956 of this Section. 

(C) Location of the septic tank, other approved pretreatment unit, pumping or dosing chamber, and 
nitrification field shall be in accordance with Rule .1950 of this Section. Horizontal distances 
from the nitrification field shall be measured from a margin two and one-half feet beyond the 
lateral and manifold pipes. 

(D) There shall be no soil disturbance of the site or repair area for an LPP system except the 
minimum required for installation. 

(E) The available space requirements of Rule .1945 of this Section shall apply. 

(3) Table IV shall be used in determining the long-term acceptance rate for LPP systems. The 
long-term acceptance rate shall be based on the most hydraulically limiting, naturally occurring soil 
horizon within two feet of the ground surface or to a depth of one foot below the trench bottom, 
whichever is deeper. 



TABLE IV 



SOIL GROUP 



SOIL TEXTURAL CLASSES 
(USD A CLASSIFICATION) 



Sands 
(With S or 
PS structure 
and clay 
mineralogy) 



Sand 
Loamy Sand 



LONG-TERM 
ACCEPTANCE RATE 



gpd/ft 2 
0.6 - 0.4 



II 



Coarse Loams 
(With S or 
PS structure 
and clay 
mineralogy) 



Sandy Loam 
Loam 



0.4 - 0.3 



III 



Fine Loams 
(With S or 
PS structure 
and clay 
mineralogy) 



Sandy Clay 
Loam 
Silt Loam 
Clay Loam 
Silty Clay 
Loam 
Silt 



0.3 - 0.15 



2165 



7:19 



NORTH CAROLINA REGISTER 



January 4, 1993 



PROPOSED RULES 



IV Clays (With Sandy Clay 0.2 - 0.05 

S or PS Silty Clay 

structure Clay 

and clay 
mineralogy) 

The long-term acceptance rate shall not exceed the mean rate for the applicable soil group for food 
service facilities, meat markets, and other places of business where accumulation of grease can 
cause premature failure of a soil absorption system. Long-term acceptance rates up to the 
maximum for the applicable soil group may be permitted for facilities where data from comparable 
facilities indicates that the grease and oil content of the effluent will be less than 30 mg/1 and the 
chemical oxygen demand (COD) will be less than 500 mg/1. 

(4) In calculating the number of square feet for the nitrification field, the design sewage flow shall be 
divided by the long-term acceptance rate from Table IV. In calculating the minimum length of 
trenches in the LPP system, the total square footage of the nitrification field shall be divided by 
five feet. 

(5) Low-pressure systems shall be designed for uniform distribution of effluent. The trenches shall 
be level and parallel to the ground elevation contours. 

(A) The maximum lateral length shall yield no more than a ten-percent difference in discharge rate 
between the first and last hole along the lateral. 

(B) Minimum hole size shall be 5/32-inch for at least two-thirds of the field lateral lines. Smaller 
holes (no less than 1/8-inch) may be used in no more than one-third of the lateral lines where 
necessary to balance flow distribution on sloping sites. However, for systems serving restaurants, 
foodstands, meat markets and other establishments where effluent is expected to have a high 
clogging potential, the minimum hole size shall be 5/32-inch. 

(C) Maximum hole spacing shall be as follows: Soil Group I, five feet; Soil Group II, six feet; Soil 
Group III, eight feet; and Soil Group IV, ten feet. 

(D) The following design provisions are required for sloping sites: 

(i) Separately valved manifolds are required for all subfield segments where the elevation 
difference between the highest and lowest laterals exceeds three feet. 

(ii) The hole spacing, hole size or both shall be adjusted to compensate for relative head 
differences between laterals branching off a common supply manifold and to compensate for 
the bottom lines receiving more effluent at the beginning and end of a dosing cycle. The 
lateral network shall be designed to achieve a ten to 30 percent higher steady state (pipe full) 
flow rate into the upper lines, relative to the lower lines, depending on the amount of 
elevation difference. 

(iii) Maximum elevation difference between the highest and lowest laterals in a field shall not 
exceed ten feet unless the flow is hydraulically split between subfield segments without 
requiring simultaneous adjustment of multiple valves. 

(E) Turn-ups shall be provided at the ends of each lateral, constructed of Schedule 40 PVC pipe or 
equivalent, and protected with sleeves of larger diameter pipe (six inches or greater). Turn-ups 
and sleeves shall be cut off and capped at or above the ground surface, designed to be protected 
from damage, and easily accessible. 

(F) The supply manifold shall be sized large enough relative to the size and number of laterals served 
so that friction losses and differential entry losses along the manifold do not result in more than 
a 15 percent variation in discharge rate between the first and last laterals. 

(i) The ratio of the supply manifold inside cross sectional area to the sum of the inside cross 

sectional areas of the laterals served shall exceed 0.7:1. 
(ii) The reduction between the manifold and connecting laterals shall be made directly off the 

manifold using reducing tees. 
(iii) cleanouts to the ground surface shall be installed at the ends of the supply manifold. 

(G) Gate valves shall be provided for pressure adjustment at the fields whenever the supply line 
exceeds 100 feet in length. Valves shall be readily accessible from the ground surface and 
adequately protected in valve boxes. 

(6) Septic tanks, pump tanks, pump dosing systems, siphons, and siphon dosing tanks shall be provided 



7:19 NORTH CAROLINA REGISTER January 4, 1993 2166 



PROPOSED RULES 



in accordance with Rule .1952 of this Section. 

(A) Design flow rate shall be based upon delivering two feet to five feet of static pressure head at the 
distal end of all lateral lines. 

(B) Dose volume shall be between five and ten times the liquid capacity of the lateral pipe dosed, plus 
the liquid capacity of the portions of manifold and supply lines which drain between doses. 

(b) FILL SYSTEM: A fill system (including new and existing fill) is a system in which all or part of the 
nitrification trench(es) is installed in fill material. A fill system, including an existing fill site, may be 
approved where soil and site conditions prohibit the installation of a conventional or modified septic tank 
system if the requirements of this Paragraph are met. 

(1) Fill systems may be installed on sites where at least the first 18 inches below the naturally 
occurring soil surface consists of soil that is suitable or provisionally suitable with respect to soil 
structure and clay mineralogy, and where organic soils, restrictive horizons, saprolite or rock are 
not encountered. Further, no soil wetness condition shall exist within the first 12 inches below the 
naturally occurring soil surface and a groundwater lowering system shall not be used to meet this 
requirement. Fill systems shall not be utilized on designated wetlands unless the proposed use is 
specifically approved in writing by the designating agency. The following requirements shall also 
be met: 

(A) Nitrification trenches shall be installed with at least 24 inches separating the trench bottom and 
any soil horizon unsuitable as to soil structure, clay mineralogy, organic soil, rock or saprolite. 
However, if a low pressure pipe system is used, the minimum separation distance shall be 18 
inches. 

(B) Nitrification trenches shall be installed with at least 18 inches separating the trench bottom and 
any soil wetness condition. This separation requirement for soil wetness conditions may be met 
with the use of a groundwater lowering system only in Soil Groups I and II, with suitable 
structure and clay mineralogy. However, if a low pressure pipe system is used, the minimum 
separation distance shall be 12 inches. 

(C) Systems shall be installed only on sites with uniform slopes less than 15 percent. Storm water 
diversions and subsurface interceptor drains or swales may be required upslope of the system. 

(D) The long-term acceptance rate shall be based on the most hydraulically limiting soil horizon 
within 18 inches of the naturally occurring soil surface or to a depth one foot below the trench 
bottom, whichever is deeper. The lowest long-term acceptance rate for the applicable soil group 
shall be used for systems installed pursuant to this Rule. However, the long-term acceptance rate 
shall not exceed 1 .0 gallons per day per square foot for gravity distribution or 0.5 gallons per day 
per square foot for low-pressure pipe systems installed on sites with at least 18 inches of Group 
I soils below the naturally occurring soil surface or to a depth of one foot below the trench 
bottom, whichever is deeper. 

(E) If the fill system uses low-pressure pipe distribution, all the requirements of Paragraph (a) of this 
Rule, except Paragraph (a)(2)(B). shall apply. Systems with a design daily flow greater than 480 
gallons per day shall use low-pressure pipe distribution. 

(F) Fill material shall have such soil texture to be classified as sand or loamy sand (Soil Group I) up 
to the top of the nitrification trenches. The final six inches of fill used to cover the system shall 
have a finer texture (such as Group II. Ill) for the establishment of a vegetative cover. Existing 
fill material shall have no more than ten percent by volume of fibrous organics, building rubble, 
or other debris and shall not have discreet layers containing greater than 35 percent of shell 
fragments. 

(G) Where fill material is added, the fill material and the existing soil shall be mixed to a depth of 
six inches below the interface. Heavy vegetative cover or organic litter shall be removed before 
the additional fill material is incorporated. 

(H) The fill system shall be constructed as an elongated berm with the long axis parallel to the ground 

elevation contours of the slope. 
(I) The side slope of the fill shall not exceed a rise to run ratio of 1:4. However, if the first 18 

inches below the naturally occurring soil surface is Group I soil, the side slope of the fill shall 

not exceed a rise to run ratio of 1:3. 
(J) The outside edge of the nitrification trench shall be located at least five feet horizontally from the 

top of the side slope. 



2167 7:19 NORTH CAROLINA REGISTER January 4, 1993 



PROPOSED RULES 



(K) The fill system shall be shaped to shed surface water and shall be stabilized with a vegetative 

cover against erosion. 
(L) The setback requirements shall be measured from the projected toe of the slope. However, if this 
setback cannot be met. the setback requirements shall be measured from a point five feet from 
the nearest edge of the nitrification trench if the following conditions are met: 
(i) Slope of the site shall not exceed two percent; 
(ii) The first 18 inches of soil beneath the naturally occurring soil surface shall consist of Group 

I soils; 
(iii) The lot or tract of land was recorded on or before December 31, 1989; and 
(iv) A condition is placed upon the Improvement Permit to require connection to a public or 
community sewage system within 90 days after such system is available for connection and 
after it is determined that 300 feet or less of sewer line is required for connection. 
(M) The available space requirements of Rule .1945 of this Section shall apply. 

(2) An existing fill site that does not meet the requirements of Paragraph (b)(1) of this Rule may be 
utilized for a sanitary sewage system if the following requirements are met: 

(A) Substantiating data are provided by the lot owner (if not readily available to the local health 
department) indicating that the fill material was placed on the site prior to July 1. 1977. 

(B) The fill material placed on the site prior to July 1, 1977 shall have such soil texture to be 
classified as sand or loamy sand (Group I) for a depth of at least 24 inches below the existing 
ground surface. This fill material shall have no more than ten percent by volume of fibrous 
organics. building rubble, or other debris. This fill shall not have discreet layers containing 
greater than 35 percent of shell fragments. However, if at least 24 inches of Group I fill material 
was in place prior to July 1. 1977. additional fill with soil texture classified as Group I may be 
added to meet the separation requirements of Paragraph (b)(2)(D) of this Rule. 

(C) Soil wetness conditions, as determined by Rule . 1942(a) in this Section, are 18 inches or greater 
below the ground surface of the fill placed on the lot prior to July 1. 1977. This requirement 
shall be met without the use of a groundwater lowering system. 

(D) Low-pressure pipe distribution shall be used and shall meet all the requirements of Paragraph (a) 
of this Rule, except (a)(2)(B). The long-term acceptance rate shall not exceed 0.5 gallons per day 
per square foot. However, for existing fill sites with 48 inches of Group I soils, conventional 
nitrification trenches utilizing a maximum long-term acceptance rate of 1 .0 gallons per day per 
square foot may be installed in lieu of low-pressure pipe systems. The minimum separation 
distance between the trench bottom and any soil wetness condition or any soil horizon unsuitable 
as to soil structure, clay mineralogy, organic soil. rock, or saprolite shall be 24 inches for low 
pressure pipe systems and 48 inches for conventional systems. This separation requirement may 
be met by adding additional Group I soil, but shall not be met with the use of a groundwater 
lowering system. Where fill is to be added, the requirements of Paragraphs (b)(1)(C). (F). (G). 
(H), (J). (K). of this Rule and the following requirements shall be met: 

(i) The side slope of the fill shall not exceed a side slope ratio of 1:3. and; 

(ii) The setback requirements shall be measured from the projected toe of the slope. However, 
if this setback cannot be met, the setback requirements shall be measured from a point five 
feet from the nearest edge of the nitrification trench if the following conditions are met: 

(I) Slope of the site shall not exceed two percent; 

(II) The lot or tract of land was recorded on or before December 31, 1989: and 

(III) A condition is placed upon the Improvement Permit to require connection to a public or 
community sewage system within 90 days after such system is available for connection and 
after it is determined that 300 feet or less of sewer line is required for connection. 

(E) The available space requirements of Rule .1945 of this Section shall apply. 

(F) The design flow shall not exceed 480 gallons per day. 

( 3 ) Other fill systems may be installed in fill approved by the local health department on a site-specific 
basis if the requirements of Paragraph (e) of this Rule nre mot m accordance with Rule . 1948(d) 
of this Section . 

fe-) — A site cla ss ified as UNSUITABLE which cannot he approved for a sy s tem in accordance with Rule 
.1056, and Paragraphs (a) or (b) of thi s Rule may be used for a ground absorption sewage treatment and 
disposa l s y s tem if written documentation, including engineering, hvdrogeologic. geologic, or soil s tud i e s . 



7:19 NORTH CAROLINA REGISTER January -/, 1993 216$ 



PROPOSED RULES 



indicate s to the local health department that the proposed system can reasonably be expected to function 
satisfactorily. Such s ite s s hall bo reclassified as PROVISIONALLY SUITABLE if the local health department 
determines that the adequate s ub s tantiating data indicate s that: 

f+-) a ground absorption s ystem can be in s talled s o that the effluent will rec e ive adequate treatment; 

f3-) the effluent will not contaminate ground water or s urface water; and 

f^-) the effluent will not be exposed on the ground surface or be discharged to s urface waters where 

it could come in contact with people, animal s , or vector s . 
The State shall review the substantiating data if requested by the local health department. 

fd-) icjlndividual aerobic sewage treatment units (ATI's) shall be sited, designed, constructed and operated 
in accordance with this Rule to serve a design unit with a design flow rate of up to 1500 gallons per day, as 
determined in Rule .1949(a) or .1949(b) of this Section. ATUs shall not be used, however, where wastes 
contain high amounts of grease and oil, including restaurants and food service facilities. The strength of the 
influent wastewater shall be similar to domestic sewage with Biological Oxygen Demand (BOD) and suspended 
solids not to exceed 300 parts per million. ATUs shall comply with the requirements of the National 
Sanitation Foundation (NSF) Standard 40 for Individual Aerobic Wastewater Treatment Plants and shall be 
classified as meeting Class I effluent quality. NSF Standard 40 for Individual Aerobic Wastewater Treatment 
Plants i- hereb\ m-)'*^^) by r c l c r c nc c in accordanc e v . i ih (i.S. 150B 1 4i c i . i ncorporated b\ reference including 
any subsequent amendments and editions. Copies of the standards may be inspected in and copies obtained 
from the Division of Environmental Health, P.O. Box 27687, Raleigh, N.C. 27611-7687 at no cost. ATUs 
shall bear the NSF mark and the NSF listed model number or shall bear the certification mark and listed 
model number of a third party certification program accredited by the American National Standards Institute 
(ANSI), pursuant to ANSI Policy and Procedures for Accreditation of Certification Programs to certify ATUs 
in accordance with NSF Standard Number 40. The ANSI Policy and Procedures for Accreditation of 
Certification Programs is hereby adopted incorporated by reference in accordance with G.S. 150B 1 4 (c) by 
reference including any subsequent amendments and editions. Copies of the standard may be inspected in and 
copies obtained from the Division of Environmental Health, P.O. Box 27687, Raleigh, N.C. 2761 1-7687 at 
no cost. ATUs shall only be permitted where the unit is to be operated and maintained by a certified 
wastewater treatment facility operator employed by or under contract to the county in which the unit is 
located, and in accordance with this Rule. 

( 1 ) ATUs shall be constructed and installed in accordance with the plans which have been approved 
by the Division of Environmental Health and shall comply with all requirements of this Rule. 
Procedures for plan review and approval shall be in accordance with Rule .1953 of this Section. 

(2) The rated capacity of ATUs listed as complying with NSF Standard 40 shall not be less than the 
design daily flow as determined by Rule .1949(a) or .1949(b) of this Section. 

(3) The following are minimum standards of design and construction of ATUs: 

(A) Blockouts in concrete ATU inlet openings shall leave a concrete thickness not less than one inch 
in the plant wall. Inlet and outlet blockouts shall be made for a minimum of four inch pipe and 
a maximum of six inch pipe. No blockouts or openings shall be permitted below the liquid level 
of the ATU. 

(B) The inlet into the ATU shall be a straight pipe. 

(C) The invert of the outlet shall be at least two inches lower in elevation than the invert of the inlet. 

(D) Interior baffle walls in concrete units shall be reinforced by the placing of six-inch by six-inch 
No. 10 gauge welded reinforcing wire. The reinforcing wire shall be bent to form an angle of 
90 degrees on the ends in order to form a leg not less than four inches long. When the wire is 
placed in the mold, the four inch legs shall lay parallel with the side wall wire and adjacent to 
it. 

(E) Access openings shall be provided in the ATU top. Access shall be provided for cleaning or 
rodding out the inlet pipe, for cleaning or clearing air or gas passage spaces, as an entrance for 
inserting the suction hose in compartments that are required to be pumped out, to allow for 
sampling the effluent, and for access to repair or maintain any system components requiring 
repair and maintenance. All access openings shall have risers sealed to the top of the ATU and 
extended at least to six inches above finished grade and designed and maintained to prevent 
surface water inflow. Rule .1950(i) of this Section shall also be met. 

(F) Concrete ATUs shall be constructed in accordance with Rule . 1954(a)(9), ( 10), (11) and ( 12) and 
.1954(b)(4) of this Section. 



2169 7:19 XORTH CAROLINA REGISTER January 4, 1993 



PROPOSED RULES 



(G) Fiberglass reinforced plastic ATUs shall be constructed with materials capable of resisting 
corrosion from sewage and sewage gases, and the active and passive loads on the unit walls, 
(i) ATUs shall have the following minimum physical properties: 

Ultimate tensile strength: 12.000 psi 

Flexural strength: 19. OCX) psi 

Flexural modulus of elasticity: 800.000 psi 

(ii) A vacuum test shall be performed on at least one ATU of each model number by an 

independent testing laboratory, in accordance with ASTM D-4021, Standard Specification for 

Glass-Fiber Reinforced Polyester Underground Petroleum Storage Tanks, which is hereby 

adopted incorporated by reference in accordance with G.S. — 150B 1 4 (c) including any 

subsequent amendments and editions. Copies of the standards may be inspected in and copies 

obtained from the Division of Environmental Health. P.O. Box 27687. Raleigh. N.C. 2761 1- 

7687 at no cost . Unit must withstand negative pressure of 2.5 pounds per square inch (69.3 

inches of water) without leakage or failure. Test results shall be included with the 

specifications that are provided to the state for approval. 

(iii) Composition of the finished unit shall be at least 30 percent fiberglass reinforcement by 

weight. Minimum wall thickness shall be one-fourth inch. However, a wall thickness of not 

less than three-sixteenth inch may be allowed in small, isolated areas of the ATU. 

(iv) Interior and exterior surfaces shall have no exposed fibers or projections, no blisters larger 

than one-fourth inch in diameter, and no pores or indentations deeper than one-sixteenth inch. 

The tank shall be watertight. 

(H) Prefabricated ATUs other than precast reinforced concrete or fiberglass reinforced plastic units 

shall be approved on an individual basis based on information furnished by the designer which 

indicates the unit will provide effectiveness equivalent to reinforced concrete or fiberglass 

reinforced plastic units. 

(I) ATUs shall bear an imprint identifying the manufacturer, serial number assigned to the 

manufacturer's plans and specifications approved by the Division of Environmental Health, and 

the liquid or working capacity of the unit. The imprint shall be located to the right of the 

blockout or opening made for the outlet pipe on the outside of the unit. ATUs shall also be 

permanently marked with the date of manufacture adjacent to the unit imprint or on the top of 

the unit directly above the imprint. 

(J) The design, construction, and operation of ATUs shall prevent bypass of wastewater. 

(K) Electrical circuits to the ATU shall be provided with manual circuit disconnects within a 

watertight, corrosion-resistant, outside enclosure (NEMA 4X or equivalent) adjacent to the ATU 

securely mounted at least 12 inches above the finished grade. Control panels provided by the 

manufacturer shall be installed in a watertight, corrosion-resistant enclosure (NEMA 4X or 

equivalent) adjacent to the unit or on the side of the facility readily visible from the unit and 

accessible by maintenance personnel. Conductors shall be conveyed to the disconnect enclosure 

and control panel through waterproof, gasproof, and corrosion-resistant conduits. Splices and 

wire junctions, if needed, shall be made outside the ATU in a watertight, corrosion-resistant 

enclosure (NEMA 4X or equivalent) securely mounted adjacent to the unit at least 12 inches 

above the finished grade. Wire grips, duct seal, or other suitable material shall be used to seal 

around wire and wire conduit openings inside the ATU and disconnect enclosure. The ATU shall 

have an alarm device or devices to warn the user or operator of a unit malfunction or a high 

water condition. The alarm shall be audible and visible by system users and securely mounted 

adjacent to the ATU, on the side of the facility in clear view of the unit, or inside the finished 

occupied space of the facility. If mounted outside, the alarm shall meet NEMA 4X standards or 

equivalent. The alarm circuit or circuits shall be supplied ahead of any ATU electrical control 

circuit overload and short circuit protective devices. 

(4) A settling tank shall be required prior to an ATU serving a design unit with a design daily flow 

greater than 500 gallons, as determined in Rule .1949(a) or .1949(b) of this Section. The liquid 

capacity of the settling tank shall be at least equal to the design daily flow as determined in Rule 



7:19 NORTH CAROLINA REGISTER January 4, 1993 2170 



PROPOSED RULES 



.1949(a) or (b) of this Section. The settling tank may either be an approved prefabricated septic 
tank or another tank specially designed for a specific individual aerobic sewage treatment plant and 
approved by the Division of Environmental Health as a part of the plans for the plant. 

(5) Ground absorption systems receiving effluent from approved ATUs may be used on sites classified 
as suitable or provisionally suitable for conventional, modified, or alternative systems in accordance 
with this Section. The following modifications to siting and design criteria shall be acceptable: 

(A) The minimum horizontal setback requirements of Rule .1950(a) of this Section shall be met. 
except as follows: 

(i) Any private water supply source, except any uncased well or spring 50 feet, 

(ii) Streams classified as WS-I 70 feet, 

(iii) Waters classified as SA 70 fe«t. 

(iv) Other coastal waters not classified as SA 35 feet. 

(v) Any other stream, canal, marsh, or other surface waters 35 feet, 

(vi) Any Class I or Class II reservoir 70 feet. 

from normal 
pool elevation. 
(vii) any permanent storm water retention pond. 35 feet. 

from flood 

pool elevation. 

(viii) Any other lake or pond 35 feet. 

from normal 
pool elevation. 

(B) The requirements of Rules ,1955(m). .1956(1). .1956(2). .1956(6). .1957(b)(1), and .1957(b)(2) 
of this Section shall be met, except as follows: 

(i) A low-pressure pipe system shall not be required where the separation between the bottom 

of the nitrification trench and any soil wetness condition is at least 12 inches, but less than 

18 inches, and more than six inches of this separation consists of Group I soils. 
(ii) The restriction in Rule . 1956(6)(a)(v) of this Section that saprolite be overlain by at least one 

foot of suitable or provisionally suitable naturally occurring soil shall not apply. 
(iii) For new fill systems, a low pressure pipe system shall not be required in order for the 

minimum separation distance between the trench bottom and any unsuitable soil horizon. 

rock, or saprolite to be reduced to 18 inches. 
(iv) For existing fill systems, the minimum separation requirements of Rule . 1957(b)(2)(D)of this 

Section shall be reduced from 48 to 36 inches for conventional systems and from 24 to 18 

inches for low-pressure pipe system. 

(C) The maximum long-term acceptance rate shall be increased by 25 percent for any ground 
absorption system in soils which are Groups I or II with suitable structure and clay mineralogy. 
No other reductions in linear footage of nitrification trench or system area shall be applied, except 
where based on an adjusted design daily sewage flow rate granted in accordance with Rule 
.1949(c) of this Section. 

(6) Prior to issuance of an Operation Permit for an ATI.', the manufacturer or his licensed 
representative shall certify that the unit has been properly installed and a contract for operation and 
maintenance shall have been executed between the unit owner and the county in accordance with 
Rule .1961(b) of this Section. It shall be a condition of the Operation Permit that subsequent 
owners of an ATI' execute such a contract. The contract shall include the specific requirements 
for maintenance and operation, responsibilities for maintenance and operation, responsibilities of 
the owner and system operator, provisions that the contract shall be in effect for as long as the 
system is in use. and other requirements for the continued proper performance of the ATU. A 
condition of the Operation Permit shall be that the unit continue to perform in accordance with 
Class I effluent quality requirements of the National Sanitation Foundation (NSF) Standard Number 
40 effective on the date the improvement permit was issued. 

(7) Performance monitoring shall be carried out by the operator. 

(A) During each inspection, the operator shall confirm proper mechanical performance, conduct a 
visual check for unusual color, clo22ins. oilv film, odors, foam, measure settleable aeration 



2171 7:19 XORTH CAROLINA REGISTER January 4, 1993 



PROPOSED RULES 



chamber solids, and ascertain the need for removing solids, backwash and cleaning of filters, and 
other maintenance activities. The ground absorption system shall also be inspected and an 
evaluation of performance shall be made. The operator shall take the necessary steps to assure 
that needed maintenance is carried out. 

(B) Semi-annually, samples shall be collected by the system operator and analyzed by a 
state-approved wastewater testing laboratory of the effluent for Five-Day Biological Oxygen 
Demand. Suspended Solids, and pH. The aeration tank shall be sampled for mixed liquor 
suspended solids. 

(C) Performance monitoring results shall be reported to the local health department and the state 
quarterly. 

(D) Remedial action and additional sampling shall be required if monitoring results or inspection 
indicate that Class I effluent standards are not met. 



Statutory Authority G.S. 130A-335(e) and (f); 130A-342. 

. 1969 EXPERIMENTAL AND INNOVATIVE 
SYSTEMS, COMPONENTS, OR 
DEVICES 

Experimental and innovative £E & I] systems are 
any wastewater systems, system components, or 
devices that are not specifically described jn Rules 
.1955, .1956. .1957. or .1958 of this Section, 
including any system for which reductions are 
proposed in the minimum horizontal or vertical 
separation requirements or increases are proposed 
to the maximum long-term acceptance rates of this 
Section. This Rule shall provide for the approval 
and permitting of E & 1 systems. 

( 1 ) An application shall be submitted in 
writing to the State for an E & I system. 
The application shall include the 



(a) 



ibi 



£3 



id] 



lei 



following, as applicable: 
description of the system and its 
proposed use, including materials used 
in construction: 

review of pertinent literature, published 
research, and previous experience and 
performance with the system: 
results of any available testing, research 
or monitoring of pilot systems or full- 
scale operational systems conducted by 
a third party research or testing 
organization: 



identity and qualifications of any 
proposed research or testing 
organization and the principal 
investigators, and an affidavit certifying 
that the organization and principal 
investigators have no conflict of interest 
and do not stand to gain financially 
from the sale of the E & \ system: 
objectives, methodology, and duration 
of any proposed research or testing: 
operation and maintenance procedures, 
system classification, proposed 



LZl 



ih] 



ill 



in 



ib] 



L^J 



ill 



ia] 



management entity and system operator: 
procedure to address system 
malfunction and replacement or 
premature termination of any proposed 
research or testing; and 
notification of any proprietary 
information, system, component, or 
device. 
The State shall review all applications 
submitted for review. The State shall 
evaluate at least the following: 
the completeness of the application, and 
whether additional information js 
needed to continue the review; 
whether the system, component or 
device meets the standards of an 
innovative system under Paragraph (3) 
of this Rule, and proposed conditions 
for use, maintenance and monitoring. 
For systems, components, or d evices 
which cannot be approved as an 
innovative system, whether approval 
shall be granted for use as an 
experimental system under Paragraph 
(4) of this Rule, and proposed 
conditions for use, research and 
maintenance. 



LhJ 



INNOVATIVE SYSTEMS: In order for 

a system, component, or device to be 

approved as an innovative system, the 

following standards shall be met: 

The system, component, or device shall 

have been demonstrated to perform 

equal or superior to a system. 

component or device which is described 

in Rules .1955. .1956. .1957 or .1958. 

based upon controlled pilot-scale 

research studies or statistically-valid 

monitoring of full-scale operational 

systems. 

Materials used in construction shall be 



7:19 



NORTH CAROLINA REGISTER 



January 4, 1993 



2172 



PROPOSED RULES 



equal or superior in physical properties 

and chemical durability, compared to 

materials used for similar purposed in 

systems, components or devices 

specifically described in Rules . 1955. 

.1956, .1957 or .1958. When a 

system, component, or device is 

approved as innovative by the State, the 

applicant shall be notified in writing. 

Such notice shall include any conditions 

for use, monitoring, and operation. A 

local health department shall issue an 

Improvement Permit for any innovative 

system approved by the State upon a 

finding that the provisions of this Rule 

including any conditions are met. Use 

of an innovative system and any 

conditions shall be described on the 

Improvement Permit and the Certificate 

of Completion or Operation Permit. 

(4) EXPERIMENTAL SYSTEMS: A 

system, component, or device which is 

not approved as an innovative system 

may be approved for use as an 

experimental system as part of a research 

or testing program which has been 

approved by the State. The research or 

testing program shall be conducted by a 

third party research or testing 

organization which has knowledge and 

experience relevant to the proposed 

research or testing and has no conflict of 

interest and does not stand to gain 

financially from the sale of the proposed 

system. 

(a) To be approved by the State, the 

proposed research or testing program 

shall include the following: 

(i) Objectives which address issues which 

do not enable the system to be 

approved as an innovative system. 

(ii) Research design and testing 

methodology which has a reasonable 

likelihood of meeting the objectives. 

(iii ) Specification of the number of 

systems proposed to be installed, the 

criteria for site selection, system 

monitoring and reporting procedures. 

and operation and maintenance 

requirements. 

The State shall notify the applicant and 

the applicable local health departments 

when the proposed research or testing 

program has been approved for an 

experimental system. 



(b) A local health department may issue an 
Improvement Permit for an 
experimental system when the following 
conditions are met: 



(i) There 



an application for an 



Improvement Permit in accordance 
with Rule . 1937(c) of this Section, 
with the proposed use of an 
experimental system specified. 

(ii) The proposed site is included as part 
of an approved research or testing 
program and any conditions specified 
for use of the system have been met. 

(iii) When an experimental system is 
proposed to serve a residence, place 
of business or place of public 
assembly, the provisions for a repair 
area and backup system of Rule 
. 1945(b) of this Section shall apply, 
except: 

(A) When an existing and properly 
functioning wastewater system is 
available for immediate use, 
including connection to a public 
or community wastewater system: 

or 

(B) When the experimental system is 
used as a repair to an existing 
malfunctioning system: or 

(C) When the experimental system is 
to serve a vehicular, portable 
structure built on a chassis and 
designed to be used as a 
residence, place of business, or 
place of public assembly without 
a permanent foundation, in which 
case sufficient available space 
shall be reserved for the installa- 
tion of a replacement system at 
least equal to the initial experi- 
mental system. 

(iv) When an experimental system is 
proposed which shall not serve a 
residence, place of business, or place 
of public assembly, a repair area or 
backup system shall not be required. 

(v) The application for an experimental 
system shall include statements that 
the property owner and proposed 
user(s) of the system are aware of its 
experimental nature, hold the local 
health department and State harmless 
regarding the installation, use, moni- 
toring and performance of the system 
and are aware that use of the system 



2173 



7:19 



NORTH CAROLINA REGISTER 



January 4, 1993 



PROPOSED RULES 



may need to be discontinued if the 
system malfunctions and is found to 
be non-repairable, or if the proposed 
research or testing program \s prema- 
turely terminated. Such statements 
shall be signed by the owner and 
proposed system user(s). 

(vi) The owner of the site on which an 
experimental system is proposed shall 
execute a easement granting rights of 
access to the system at reasonable 
hours for monitoring and evaluation 
to the research or testing organiza- 
tion. This easement shall remain 
valid as long as the system is to be 
part of the proposed research or 
testing program. The easement shall 
be recorded with the county register 
of deeds. 

(vii) Provisions shall be made for operation 
and maintenance of the system. 

(c) Any special conditions required for the 
installation of the experimental system 
shall be specified [n the Improvement 
Permit. Use of an experimental system 
and any conditions shall be described 
on the Improvement Permit and any 
subsequent operation permits, with 
provisions for a repair area and backup 
system specified. A condition of the 
Improvement Permit shall be that the 
installation be under the direct field 
supervision of the research or testing 
organization. 

(d) All proposed permits for experimental 
systems shall be reviewed by the State 
and found to be consistent with the 
approved research or testing program 
prior to issuance by the local health 
department. 

(e) Upon completion of the installation and 
prior to use, an Experimental System 
Operation Permit (ESOP) shall be 
issued by the local health department. 
The ESOP shall be valid for a specified 
period of time not to exceed five years. 
Special maintenance, monitoring and 
testing requirements shall be specified 
as permit conditions, in accordance 
with the approved research or testing 
program. Failure to carry out these 
conditions shall be grounds for permit 
suspension or revocation. 

(f) Prior to expiration of the ESOP and 
based upon satisfactory system perfor- 



mance as determined during the re- 
search or testing program, the local 
health department shall issue an Opera- 
tion Permit. Premature termination of 
the research or testing program shall be 
grounds for ESOP suspension or revo- 
cation, 
(g) Upon completion of monitoring, re- 
search and testing, the research or 
testing organization shall prepare a final 
report including recommendations on 
future use of the system. The State may 
recommend incorporation of the system 
into the rules as a conventional, modi- 
fied or alternative system; or use as an 
innovative system in accordance with 
Paragraph (3) of this Rule; or further 
research or testing. 
(5) The State shall suspend or revoke the 
approval of an E & I system or modify 
the conditions specified for system use 
upon a finding that the information sub- 
mitted in the application \s changed or 
falsified, subsequent experience with the 
system results in altered conclusions 
about system performance or design, or 
when superseded by future rules. 

Statutory Authority- G. S. 130A-335(e) and (f); 

130A-343. 



7:19 



NORTH CAROLINA REGISTER 



January 4, 1993 



2174 



PROPOSED RULES 






[Sotice is hereby given in accordance with G.S. 
150B-21.2 that the EHNR-Commission for Health 
Services intends to amend rules cited as 15A 
NCAC 19B .0313, .0320 - .0321 . .0503. 

1 he proposed effective date of this action is April 
1. 1993. 

1 he public hearing will be conducted at 1:30 
p.m. on January 20. 1993 at the Highway Build- 
ing. First Floor Auditorium. 1 South Wilmington 
Street, Raleigh, North Carolina. 



R 



eason for Proposed Action: 



ISA NCAC 19B .0313 - To specify requirements of 
evaluating breath-test instruments and improve the 
efficiency of the statewide alcohol testing program. 

ISA NCAC 19B .0320 and .0321 - To improve the 
efficiency of Intoxilyzer 5000 operational and 
maintenance procedures. 

15A NCAC 19B .0503 - To add three additional 
alcohol screening test devices to the approved list. 

Comment Procedures: All persons interested in 

these matters are invited to attend the public 
hearing. Written comments may be presented at 
the public hearing or submitted to John P. 
Barkley. Department of Justice, P.O. Box 629, 
Raleigh. NC 27602-0629. (919)733-4618. If you 
desire to speak at the public hearing, notify John 
P. Barkley at least 3 days prior to the public 
hearing. Oral presentation lengths may be limited 
depending on the number of people that wish to 
speak at the public hearing. Onlx persons who 
have made comments at a public hearing or who 
have submitted written comments will be allowed 
to speak at the Commission meeting. Continents 
made at the Commission meeting must either 
clarify previous comments or address proposed 
changes from staff pursuant to comments made 
during the public hearing process. 

IT IS VERY IMPORTANT THAT ALL 
INTERESTED AND POTENTIALLY AFFECTED 
PERSONS. GROUPS. BUSINESSES. 
ASSOCIATIONS. INSTITUTIONS. OR AGENCIES 



MAKE THEIR VIEWS AND OPINIONS KNOWN 
TO THE COMMISSION FOR HEALTH SERVICES 
THROUGH THE PUBLIC HEARING AND 
COMMENT PROCESS. WHETHER THEY SUP- 
PORT OR OPPOSE ANY OR ALL PROVISIONS 
OF THE PROPOSED RULES. THE COMMIS- 
SION MAY MAKE CHANGES TO THE R ULES A T 
THE COMMISSION MEETING IF THE CHANGES 
COMPLY WITH G.S. 150B-21 .2(f). 

CHAPTER 19 - HEALTH: EPIDEMIOLOGY 

SUBCHAPTER 19B - INJURY CONTROL 

SECTION .0300 - BREATH ALCOHOL 
TEST REGULATIONS 

.0313 BREATH-TESTING INSTRUMENTS: 
REPORTING OF SEQUENTIAL 
TESTS 

(a) The standards for the approval of breath- 
testing instruments are as follows: 

(1) The commission approves the method 
of performing chemical analyses 
through the use of breath-testing instru- 
ments of a design and of a model spe- 
cifically approved by the commission as 
meeting, to its satisfaction, standards of 
accuracy, reliability, convenience and 
efficiency of operation. 

(2) The Injury Control Section shall evalu- 
ate and recommend to the Commission 
only those breath-testing instruments 
which meet the minimum requirements 
as set forth m the current state purchase 
and contract bid specifications for 
automated evidential breath alcohol 
testing instruments. Such evaluations 
shall be conducted only when deemed 
necessary or appropriate by the Direc- 
tor or his representative to improve the 
efficiency of the statewide alcohol 
testing program. 

f2-) (3) The succeeding rules of this Section 
establish operational and preventive 
maintenance procedures for 
breath-testing instruments approved by 
the commission. 

(b) The standards for the reporting of sequential 
tests are as follows: 

(1) In recording the results of a chemical 
analysis under G.S. 20-139. 1(e) and in 
reporting results for use in court or in 
an administrative proceeding, the chem- 
ical analyst shall report the results of all 



2175 



7:19 



NORTH CAROLINA REGISTER 



Januan* 4, 1993 



PROPOSED RULES 



tests of breath performed in conducting 
the chemical analysis. These results 
may be used for all relevant purposes, 
but these results may not be used to 
prove a person's particular alcohol 
concentration unless a pair of consecu- 
tively administered tests do not differ 
from each other by an alcohol concen- 
tration of greater than 0.02. 
(2) In proceedings in court and before 
administrative agencies, the state may 
use all breath-test procedures and re- 
sults for all relevant purposes, but when 
there is a difference in readings, the 
state may use only the lower of the two 
consecutive readings that meet the 
requirements of Paragraph (b) to prove 
a person's particular alcohol concentra- 
tion. "Particular alcohol concentration" 
is an alcohol concentration that has 
legal significance under G.S. 
20-138. 1(a)(2), 20- 1 6.5(b)(4), 
20- 179(d)(1), and 20-179(m). 

Statutory Authority G.S. 20-1 6. 5(j); 20-1 39. 1(h). 

.0320 INTOXILYZER: MODEL 5000 

The operational procedures to be followed in 
using the Intoxilyzer, Model 5000 are: 

fH In s ure observation period requirements 

have been met; 

(1) Insure instrument displays time and date; 
f2-) Insure instrument displays proper time 

and date; 

(2) Insure observation period requirements 
have been met; 

(3) Press "START TEST"- when "INSERT 
CARD" appears, insert test record; 

(4) Enter appropriate information; 

(5) Insure instrument di s play s expected re 
s uit s from the alcoholic breath s imulator; 
Verify instrument calibration; 

(6) When "PLEASE BLOW" appears, collect 
breath sample; 

(7) When "PLEASE BLOW" appears, collect 
breath sample; 

(8) When test record ejects, remove^ and 
record times and result s 

If the alcohol concentrations differ by more than 
0.02, a third or subsequent test shall be adminis- 
tered as soon as feasible by repeating steps (1) 
through (6). (7) if necessary, and (8K 1 as applica- 
ble. 

Statutory Authority G.S. 20-139. 1(h). 



.0321 PREVENTIVE MAINTENANCE: 
INTOXILYZER: MODEL 5000 

The preventive maintenance procedures for the 
Intoxilyzer Model 5000 to be followed at least 
once every four months are: 

(1) Verify alcoholic breath simulator ther- 
mometer shows 34 degrees, plus or 
minus .2 degree centigrade; 

(2) Verify instrument displays proper time 
and date; 

(3) Press "START TEST"- when "INSERT 
CARD" appears, insert test record; 

(4) Enter appropriate information; 

(5) Verify instrument displays — expected 
results from the alcoholic breath Simula 
tef calibration; 



(6) When "PLEASE BLOW" appears, collect 
breath sample; 

(7) When "PLEASE BLOW" appears, collect 
breath sample; 

(8) When test record ejects, remove and 
record time s and result s; 

(9) Verify Diagnostic Program; 

(10) Verify alcoholic breath simulator solution 
is being changed every four months or 
after 125 tests, whichever occurs first. 

A signed original of the preventive maintenance 
checklist shall be kept on file for at least three 
years. 

Statutory Authority G.S. 20-1 39.1 (h)(h4). 

SECTION .0500 - ALCOHOL SCREENING 
TEST DEVICES 

.0503 APPROVED ALCOHOL SCREENING 
TEST DEVICES: CALIBRATION 

(a) The following breath alcohol screening test 
devices are approved as to type and make: 

(1) ALCO-SENSOR (with two-digit dis- 
play), made by Intoximeters, Inc. 

(2) ALCO-SENSOR III (with three-digit 
display), made by Intoximeters, Inc. 

(3) BREATH-ALCOHOL TESTER MOD- 
EL BT-3, made by RepCo., Ltd. 

(4) ALCOTEC BREATH-TESTER, made 
by RepCo., Ltd. 

(5) ALCO-SENSOR IV, manufactured by 
Intoximeters, Inc. 

(6] PBA 3000, manufactured by Life Loc, 

Inc. 
(7) SD-2, manufactured by CML Inc. 

(b) Calibration of alcohol screening test devices 
shall be verified at least once during each 30 day 
period of use by employment of a control sample 



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2176 



PROPOSED RULES 



from an alcoholic breath simulator, or an etha- 
nol/gas standard. The device shall be deemed 
properly calibrated when the result of 0.09 or 0. 10 
is obtained. 

( 1 ) Alcoholic breath simulators used exclu- 
sively for calibration of alcohol screen- 
ing test devices shall have the solution 
changed every 30 days or after 25 
calibration tests, whichever occurs first. 

(2) Requirements of Paragraph (b) and 
■Subparagraph (b)(1) of this Rule shall 
be recorded on an alcoholic breath 
simulator log designed by the Injury 
Control Section and maintained by the 
user agency. 

Statutory- Authority G.S. 20-16.3. 



changes from staff pursuant to comments made 
during the public hearing process. 

IT IS VERY IMPORTANT THAT ALL INTERESTED 
AND POTENTIALLY AFFECTED PERSONS, GROUPS, 
BUSINESSES. ASSOCIATIONS. INSTITUTIONS. OR 
AGENCIES MAKE THEIR VIEWS AND OPINIONS 
KNOWN TO THE COMMISSION FOR HEALTH 
SERVICES THROUGH THE PUBLIC HEARING AND 
COMMENT PROCESS. WHETHER THEY SUPPORT 
OR OPPOSE ANY OR ALL PROVISIONS OF THE 
PROPOSED RULES. THE COMMISSION MA Y MAKE 
CHANGES TO THE RULES AT THE COMMISSION 
MEETING IF THE CHANGES COMPLY WITH G.S. 
I5OB-21.20. 

CHAPTER 20 
LABORATORY SERVICES 



^c Ifi >fi >fi '^ ¥ Sfi 



IVotice is hereby given in accordance with G.S. 
150B-21.2 that the EHNR - Commission for Health 
Services intends to amend rules cited as 15A 
NCAC 20D .0233 - .0235. .0243. .0248. 

1 he proposed effective date of this action is April 
1. 1993. 

1 he public hearing will be conducted at 1:30 
p.m. on January 20. 1993 at the Highway Build- 
ing. First Floor Auditorium, 1 South Wilmington 
Street, Raleigh, North Carolina. 



ixeason for Proposed Action: 
clarify the current regulations. 



To correct and 



Ksomment Procedures: All persons interested in 

these matters are invited to attend the public 
hearing. Written comments may be presented at 
the public hearing or submitted to John P. 
Barkley, Department of Justice. P.O. Box 629. 
Raleigh, NC 27602-0629. (919)733-4618. If you 
desire to speak at the public hearing, notify John 
P. Barkley at least 3 days prior to the public 
hearing. Oral presentation lengths may be limited 
depending on the number of people that wish to 
speak at the public hearing. Onlx persons who 
have made comments at a public hearing or who 
have submitted written comments will be allowed 
to speak at the Commission meeting. Comments 
made at the Commission meeting must either 
clarify previous comments or address proposed 



SUBCHAPTER 20D - CERTIFICATION AND 
IMPROVEMENT 

SECTION .0200 - LABORATORY 
CERTIFICATION 

.0233 CERTIFICATION. CERTIFICATION 
RENEWAL AND FEES 

(a) The Department of Environment, Health, 
and Natural Resources shall grant certification for 
the test categories requested upon finding that a 
laboratory meets the minimum requirements set 
forth in this Section. 

(b) A laboratory may renew its certification 
every year by payment of the certification fee by 
December 1 of the preceding year. If the fee has 
not been paid by December 3 1 of each your, the 
laboratory's certification shall not be renewed for 
the next year, and the laboratory s hall apply for 
recertification — pursuant to — R-t*4* — .0235 — of this 
■Section. — In addition to payment of the certification 



§e 



-pa? 
on site — evaluation — by — a — laboratory 



certification cvaluator and compliance with the 
minimum requirements of this Section arc required 
for renewal. A laboratory which renews its 
certification shall continue to meet the minimum 
requirements of this Section in accordance with 
15 A NCAC 20D .0234. 

(c) The certificate and information pertaining to 
certification shall remain the property of the 
Department of Environment. Health, and Natural 
Resources and shall be surrendered upon 
decertification pursuant to Rule .0234 of this 
Section. All certification information shall be 
available for public access pursuant to Chapter 1 32 
of North Carolina General Statutes. 

(d) The certification fee shall be twenty dollars 



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PROPOSED RULES 



($20.00) per analyte. The minimum and maximum 
fee per analyte group shall be as set out in G.S. 
130A-326(7). The analyte groups are as follows: 

(1) inorganic chemistry; 

(2) organic chemistry 1 (synthetic organic 
chemicals); 

(3) organic chemistry II (volatile organic 
chemicals); 

(4) total and fecal coliforms; and 

(5) radiochemistry. 

The certification fee shall not be prorated nor 
refunded. Twenty percent shall be due at the time 
of the application. 
Statutory Authority G.S. 130A-315; 130A-326. 

.0234 CRITERIA AND PROCEDURES: 
DECERTIFICATION/DENIAL/ 
DOWNGRADING 

(a) The Department of Environment, Health, 
and Natural Resources or its delegate may 
downgrade or deny laboratory certification if the 
laboratory: 

(1) Demonstrates incompetence or made 
consistent errors in analyses; 



m- 



Failed to correctly analyze performance 



evaluation — s ample s , — including — United 

States Environmental Protection Agency 

water study, double blind, blind, and 

on site s amples, or failed to report the 

results within the specified time; 

0) (2jFailed to report analytical results of 

performance evaluation samples or 

compliance samples or maintain records 

as required by this Section and the 

Rules Governing Public Water Supplies 

in 15A NCAC 18C .1500; 

{4) (3jFailed to maintain facilities and 

equipment in accordance with the 

minimum requirements of this Section; 

{§) [4)Failed to notify the certification 

evaluator of major changes such as 

personnel, equipment, or laboratory 

location; or 

{6) (5jViolated or aided and abetted in the 

violation of any provisions of the rules 

of this Section; 

(b) A downgraded laboratory with provisional 

certification may continue to perform analyses. 

The provisional status shall continue for at least 

six months. At the end of six months the 

laboratory certification shall be reinstated if the 

laboratory has made corrections and is in 

compliance with the minimum requirements for 

certification. If no corrections have been made the 

laboratory certification may be revoked. 



(c) The Department of Environment, Health, 
and Natural Resources or its delegate may 
decertify or deny laboratory certification when a 
laboratory or its employees have done any of the 
following: 

( 1 ) Knowingly made false statements on 
any documents associated with 
certification; 

(2) Falsified results of analyses; 

(3) Submitted performance evaluation 
samples used for certification 
determination to another laboratory for 
analysis; 

(4) Failed to employ approved laboratory 
methodology in the performance of the 
analyses required by 15A NCAC 18C 
.1500; 

(5) Repeatedly failed to correctly analyze 
performance evaluation samples 
including United States EPA water 
study, double blind, blind, and on-site 
samples or report the results within the 
specified time in accordance with the 
requirements of I5A NCAC 20D .0243 
and .0251; 

(6) Repeatedly failed to report analytical 
results of performance evaluation 
samples or compliance samples or 
maintain records as required by this 
Section and the Rules Governing Public 
Water Supplies in 15A NCAC 18C; 

(7) Failed to satisfy the certification 
evaluator that the laboratory has 
corrected deviations identified during 
the on-site visit within 30 days; or 

(8) Violated or aided and abetted in the 
violation of any provisions of the rules 
of this Section. 

(d) The Department of Environment, Health, 
and Natural Resources or its delegate shall notify 
a laboratory of its intent to decertify, downgrade 
to provisional status or deny certification. The 
notice shall be in writing and include reasons for 
the decision and shall be delivered by certified 
mail. 

(e) This Rule shall not preclude informal 
conferences concerning a decision to decertify, 
downgrade to provisional status or deny 
certification. 

Statutory Authority G.S 130A-315. 

.0235 RECERTIFICATION 

(a) A laboratory is eligible for recertification six 
months after decertification, except in the 



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2178 



PROPOSED RULES 



following instances: 

( 1 ) A laboratory which lost certification for 
false statements on documents, falsified 
analytical results, or submitted official 
performance samples to another 
laboratory, is eligible for recertification 
one year after decertification. 
Application for recertification shall be 
made in the same way as application for 
certification as contained in Rule .0233 
of this Section; 

(2) A laboratory which lost certification for 
failure to correctly analyze performance 
evaluation samples is eligible for 
recertification 30 days after 
decertification and after satisfying Rule 
.0243(b)(4) or .0251f+)|3j, or both of 
this Section. 

(b) A laboratory for which certification was not 
renewed for failure to pay the certification fee by 
the date required in Rule .0233 of this Section is 
eligible for recertification 60 days after paying the 
overdue fee. 

Statutory Authority G.S. 130A-315; 130A-326. 

.0243 CHEMISTRY QUALITY ASSURANCE 

(a) The following general requirements for 
chemistry quality assurance (QA) shall be met: 

(1) All quality control information shall be 
available for inspection by the certifica- 
tion officer; 

(2) A manual of analytical methods and the 
laboratory's QA plan shall be available 
to the analysts; 

(3) Class S weights or higher quality 
weights shall be available to make 
periodic checks on the accuracy of the 
balances. Checks shall be within range 
of the manufacturer's guidelines. A 
record of these checks shall be available 
for inspection. The specific checks and 
their frequency are to be as prescribed 
in the laboratory's QA plan or the 
laboratory's operations manual. These 
checks shall be performed at least once 
a month. 

(4) Color standards or their equivalent, 
such as built-in internal standards, shall 
be available to verify wavelength set- 
tings on spectrophotometers. These 
checks shall be within the 
manufacturer's tolerance limits. A 
record of the checks shall be available 
for inspection. The specific checks and 



their frequency shall be as prescribed in 
the laboratory's QA plan or the 
laboratory's operations manual. These 
checks shall be performed at least every 
six months, 
(b) The laboratory shall analyze performance 
samples as follows: 



(1) 



(2) 



(3) 



(4) 



(5) 



United States Environmental Protection 
Agency performance evaluation samples 
shall be analyzed semi-annually. 
Results shall be within control limits 
established by EPA for each analyte for 
which the laboratory is or wishes to be 
certified. 

Double blind and blind samples shall be 
analyzed when submitted to a certified 
laboratory and results shall be within 
established control limits; these data 
shall be of equal weight to the EPA 
performance evaluation sample data and 
on site quality control sample data in 
determining the laboratory's 
certification status. 

On-site quality control samples shall be 
analyzed when presented to the 
laboratory by the certification evaluator 
and results shall be within established 
control limits. These data shall be of 
equal weight to the EPA performance 
evaluation sample data and the double 
blind sample data in determining the 
laboratory's certification status. 
A performance level of 75 percent shall 
be maintained for each analyte for 
which a laboratory is or wishes to be 
certified. This 75 percent average shall 
be calculated from the ten most recent 
performance sample data points from 
the EPA water studies, double-blind, 
blind, and on-site samples. In the event 
the laboratory does not have ten data 
points, the 75 percent average will be 
calculated on the existing data points, 
with a minimum of four data points 
needed before a determination is made. 



Unacceptable performance on any of 
the samples in Paragraph (b) of this 
Rule shall be corrected and explained in 
writing within 30 days and submitted to 
the certification evaluator. 
(c) The minimum daily quality control (QC) for 
chemistry shall be as follows: 

(1) Inorganic Contaminants: 

(A) At the beginning of each day thai 
samples are to be analyzed, a standard 



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PROPOSED RULES 



curve composed of at least a reagent 
blank and three standards covering the 
sample concentration range shall be 
prepared. 

(B) The laboratory shall analyze a QC 
sample (EPA QC sample or equiva- 
lent) at the beginning of the sample 
run, at the end of the sample run, and 
every 20 samples, with recoveries not 
to exceed + 10 percent of the true 
concentration. The source of this QC 
sample shall be different from the 
source used for the calibration stan- 
dards in Paragraph Subparagraph 
(c)(1)(A) of this Rule. 

(C) The laboratory shall run an additional 
standard or QC check at the 
laboratory's lowest detectable limit 
for the particular analyte. The labo- 
ratory shall not report a value lower 
than the lowest standard or QC check 
analyzed. 

(D) The laboratory shall add a known 
spike to a minimum of 10 percent of 
the routine samples (except when the 
method specifies a different percent- 
age, i.e. furnace methods) to deter- 
mine if the entire analytical system is 
in control. The spike concentration 
shall not be substantially less than the 
background concentration of the 
sample selected for spiking. The 
spike recoveries shall not exceed _+ 
10 percent of the true value. 

(E) All compliance samples analyzed by 
graphite furnace shall be spiked to 
determine absence of matrix interfer- 
ences with recoveries _+ 10 percent of 
the true value of the spike concentra- 
tion. 

(F) The laboratory shall run a duplicate 
sample every 10 samples with dupli- 
cate values within +, 10 percent of 
each other. 

(G) Precision and accuracy data may be 
computed from the analyses of check 
samples of known value used routine- 
ly in each analytical procedure. This 
data shall be available for inspection 
by the laboratory evaluator. 

(2) Organic Contaminants: 

(A) Quality control specified in the ap- 
proved methods referenced in Rule 
.0241 of this Section shall be followed. 

(B) Analysis for regulated volatile organic 



chemicals under 15A NCAC 18C 
.1515 shall only be conducted by 
laboratories that have received 
conditional approval by EPA or the 
Department according to 40 C.F.R. 
141.24(g)(10) and (11) which is 
hereby incorporated by reference 
including any subsequent amendments 
and editions. A copy is available for 
inspection at the Department of 
Environment, Health, and Natural 
Resources, Division of Laboratory 
Services, 306 North Wilmington 
Street. Raleigh, North Carolina. 
Copies of 40 CFR 141-143 may be 
obtained by contacting the EPA 
Drinking Water Hotline at 
800-426-4791 at no charge. 
(C) Analysis for unregulated volatile 
organic chemicals under 15A NCAC 
1 8C .1516 shall only be conducted by 
laboratories approved under 
Subparagraph (c)(2)(B) of this Rule. 
In addition to the requirements of 
Subparagraph (c)(2)(B) of this Rule, 
each laboratory analyzing for EDB 
and DBCP shall achieve a method 
detection limit for EDB and DBCP of 
0.00002 mg/1, according to the 
procedures in Appendix B of 40 
C.F.R. Part 136 which is hereby 
incorporated by reference including 
any subsequent amendments and 
editions. A copy may be obtained at 
no charge by contacting the 
Department of Environment, Health, 
and Natural Resources. Division of 
Laboratory Services, 306 North 
Wilmington Street, Raleigh, North 
Carolina. 

Statutory Authority G.S. 130A-315. 

.0248 MICROBIOLOGY GENERAL 
LABORATORY PRACTICES 

(a) The general laboratory practices for microbi- 
ological analyses shall be in accordance with those 
listed in the EPA "Manual for the Certification of 
Laboratories Analyzing Drinking Water", Chapter 
5, Section 4, General Laboratory Practices, which 
is hereby incorporated by reference including any 
subsequent amendments and editions, except that 
Sections 4 .6. 1 4.7. 1 through 4.9 are not 
incorporated by reference. A copy is available for 
inspection at the Department of Environment, 



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2180 



PROPOSED RULES 



Health, and Natural Resources. Division of 
Laboratory Services, 306 North Wilmington 
Street. Raleigh. North Carolina. Nonprofit 
organizations or government agencies may obtain 
a copy by contacting the EPA Drinking Water 
Hotline at 800-426-4791 . Other organizations may 
obtain a copy from the National Technical 
Information Service at 800-336-4700 for $35.00. 
(b) In addition, the following laboratory 
practices shall be followed: 

(1) Media - General Requirements. 

Check each lot of medium with 
positive and negative culture controls. 

(2) Membrane Filter Media: 

(A) Use m-Endo broth or agar or LES 
Endo broth or agar in the single step 
or enrichment techniques. Ensure 
that ethanol used in rehydration 
procedure is not denatured. Prepare 
medium in a sterile flask and use a 
boiling water bath or. if constantly 
attended, a hot plate with a stir bar to 
bring medium to the boiling point. 
Do not boil medium. Final pH shall 
be 7.2 ±0.2. 

(B) Refrigerate MF broth no longer than 
96 hours, poured MF agar plates no 
longer than two weeks, and ampouled 
m-Endo broth in accordance with 
manufacturer's expiration date. 

(3) Multiple Tube Fermentation (MTF) 
Media: 

(A) Use double strength lauryl sulfate 
broth or lactose broth in the 
presumptive test and single strength 
brilliant green lactose bile (BGLB) 
broth in the confirmed test. 
Autoclave media at 1 2 1 "C for 12 
minutes. Final pH shall be 6.8 ± 0.2 
or 7.2 ± 0.2 for BGLB broth. 

(B) If MTF media are refrigerated after 
sterilization, incubate overnight at 
35"C ± 0.5"C before use. Discard 
tubes showing growth or bubbles. 
Use MTF media prepared in tubes 
with loose fitting closures within one 
week. Store broth media in screw 
cap tubes or bottles no longer than 
three months, provided media are 
stored in the dark. Discard media if 
evaporation exceeds 10 percent of 
original volume. 

(C) LES Endo agar shall be used for the 
completed test. Refrigerate medium 
and use within two weeks. 



(4) Clark's Total Coliform Medium: 

(A) Autoclave for 12 minutes at 121°C. 
Allow space between bottles. 

(B) Final pH shall be 6.8 ±0.2. 

(C) Store prepared medium in screw 
capped culture bottle no longer than 
three months; discard if evaporation 
exceeds 10 percent of original 
volume. 

(5) EC Medium (for fecal coliforms): 

(A) Autoclave for 12 minutes at 121°C. 

(B) Examine tubes after sterilization to 
insure that inverted inner tubes are 
free of air bubbles and that the vials 
are at least partially covered with 
medium. 

(C) Incubate refrigerated sterilized 
medium overnight at 35'^ ± 0.5°C; 
discard tubes that show growth or 
bubbles. 

(D) Store prepared medium in screw cap 
tubes. 

(E) Final pH shall be 6.9 ±0.2. 

(6) EC + MUG Medium (for detection of 
fecal coliforms-E. coli) 

(A) Autoclave medium at 121°C (gas 
tubes shall not be used) 

(B) Final pH shall be 6.9 ±0.2 

(C) Store prepared medium in screw cap 
tubes no longer than three months. 

(7) MMO-MUG Test Medium (for Total 
Coliform and E. C-&H coli ): 

(A) The laboratory shall not prepare this 
medium from basic ingredients. 

(B) Each lot purchased shall be tested for 
performance by inoculation with three 
control bacteria: Escherichia coli. a 
total coliform other than E. coli (e.g.. 
Klebsiella pneumoniae) and a 
non-coliform (e.g.. Pseudomonas 
aeruginosa). 

These control organisms can be stock 
cultures or commercially available 
discs impregnated with the organism. 
Incubate these controls at 35"C ± 
0.5°C for 24 hours, and read and 
record result. 

(C) Do not autoclave. 

(8) Fecal Coliform Membrane Filter 
Medium 

(for enumeration of fecal coliform in 

source water): 
(A) Rehydrate medium in reagent water 
containing 10 ml of 1 percent rosolic 
acid in 2N NaOH. Brina it to the 



2181 



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PROPOSED RULES 



boiling point; do not autoclave. 

(B) Autoclave for 12 minutes at 121°C. 

(C) Final pH shall be 7.4 + 0.2. 

(D) Refrigerate unused prepared medium; 
discard after 96 hours. 

(9) Heterotrophic Plate Count (HPC) 
Medium: 

(A) Autoclave HPC agar at 121°C for 15 
minutes. 

(B) Final pH shall be 7.0 + 0.2. 

(C) Temper melted agar at 44°-46°C 
before pouring. 

(D) Hold melted agar no longer than four 
hours. Do not melt sterile agar 
medium more than once. 

Statutory Authority G.S. 130A-315. 

IVotice is hereby given in accordance with G.S. 
150B-21.2 that the EHNR-Commission for Health 
Services intends to amend rules cited as 15 A 
NCA C 24A .0101, . 0502 - . 0503. 

1 he proposed effective date of this action is April 
1. 1993. 

1 he public hearing will be conducted at 1:30 
p.m. on January 20. 1993 at the Highway Build- 
ing, First Floor Auditorium, I South Wilmington 
Street, Raleigh, North Carolina. 

MXeason for Proposed Actions: 

15 A NCAC24A .0101 - To establish an annual fee 
for persons who have registered notice of rule 
making. Tliis fee will cover copying and mailing 
costs pursuant to 150B-21.2(b). 

15A NCAC 24A .0502 - Tin- current rule for 
terminating financial eligibility gives the applicant 
15 days to show why financial eligibility should not 
be terminated after we have notified him that we 
believe financial eligibility was established based 
on incorrect information on the application form. 
After that, another 15 day period is allowed for the 
applicant to appeal the decision. We are advised 
that this rule is in conflict with G.S. 130A-23 
which requires a 60 day period for filing an appeal. 

15 A NCAC 24A .0503 - The current rule refers to 



the 15 day appeal period which we are changing 
to 60 days in .0502, therefore we are deleting 
reference to the 15 day appeal period. We are 
also creating a provision for holding Authorization 
Requests received while financial eligibility is 
being investigated until a decision about termina- 
tion of eligibility is made. 

Ksomment Procedures: All persons interested in 
these matters are invited to attend the public 
hearing. Written comments may be presented at 
the public hearing or submitted to John P. 
Barkley, Department of Justice, P. O. Box 629, 
Raleigh, NC 27602-0629, (919)733-4618. If you 
desire to speak at the public hearing, notify John 
P. Barkley at least 3 days prior to the public 
hearing. Oral presentation lengths may be limited 
depending on the number of people that wish to 
speak at the public hearing. Only persons who 
have made comments at a public hearing or who 
have submitted written comments will be allowed 
to speak at the Commission meeting. Comments 
made at the Commission meeting must either 
clarify previous comments or address proposed 
changes from staff pursuant to comments made 
during the public hearing process. 

IT IS VERY IMPORTANT THAT ALL 
INTERESTED AND POTENTIALLY AFFECTED 
PERSONS. GROUPS, BUSINESSES. 
ASSOCIATIONS, INSTITUTIONS, OR AGENCIES 
MAKE THEIR VIEWS AND OPINIONS KNOWN 
TO THE COMMISSION FOR HEALTH SERVICES 
THROUGH THE PUBLIC HEARING AND 
COMMENT PROCESS, WHETHER THEY 
SUPPORT OR OPPOSE ANY OR ALL 
PROVISIONS OF THE PROPOSED RULES. THE 
COMMISSION MA Y MAKE CHANGES TO THE 
R ULES A T THE COMMISSION MEETING IF THE 
CHANGES COMPLY WITH G.S. 150B-21.2(f). 

CHAPTER 24 - GENERAL PROCEDURES 
FOR PUBLIC HEALTH PROGRAMS 

SUBCHAPTER 24A - PAYMENT 
PROGRAMS 

SECTION .0100 - GENERAL PROVISIONS 

.0101 GENERAL 

(a) The purpose of this Subchapter is to establish 
uniform policies and procedures for the 
administration of all Department of Environment. 
Health, and Natural Resources' payment programs. 



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2182 



PROPOSED RULES 



These rules are intended to facilitate efficient 
financial eligibility and payment mechanisms with 
a mutual goal of the Department and the providers 
to render appropriate services to eligible patients. 

(b) In the event of conflict between the rules in 
this Subchapter and the rules adopted by the 
various payment programs, the rules of this 
Subchapter will control. 

(c) The rules of this Subchapter shall not apply 
to the North Carolina Hemophilia Assistance Plan. 
15A NCAC 21F .1100 or to the Home Health 
Program. 15A NCAC 16A .0200. 

(d) Persons who wish to receive rule-making 
notices concerning the rules m this Subchapter 
must submit a written request to the Purchase of 
Medical Care Services Section. P.O. Box 27687. 
Raleigh. N.C. 27611-7687. The request must 
specify the calendar year during which the person 
wishes to receive the notices. A check for ten 
dollars ($10.00) made payable to the N.C. 
Department of Environment, Health, and Natural 
Resources must be enclosed with each request to 
cover the cost of printing and mailing the notices 
for the year specified. The fee is no n- refundable 
if there are no notices during the year. 

Statutory Authority G.S. 130A-5/3); 130A-124; 
} 30 A- 127; 130 A- 1 29; 130A-205. 

SECTION .0500 - QUALITY CONTROL 

.0502 TERMINATION OF FINANCIAL 
ELIGIBILITY 

The Department shall take the following steps in 
order to terminate a person's financial eligibility 
which is based upon on incorrect information: 

( 1 ) Notice shall be given to the applicant and 
the financial eligibility interviewer that 
the Department believe s has determined 
that the financial eligibility form was 
contains established based on incorrect 
information that materially affected the 
per s on' s financial el i g i bility presented on 
the financial eligibility form, the 
applicant is not financially eligible, and 
the Department has made a tentative 
decision to terminate financial eligibility . 

(2) After — tlw 15 day period. if- — tbe 

Department — determines — that — financia l 
eligibility s hall be terminated, notice shall 
be given to the applicant, the interviewer 
and the provider that the Department hns 
made a tentative — deci s ion to term i nate 
financial eligibility. — The applicant shall 
be given 15 day s to reque s t an appea l . 



The applicant and the financial eligibility 
interviewer shall be given 15 days to 
provide additional information to show 
why eligibility should not be terminated. 

(3) If no appeal — is made within — 15 days, 
financial eligibility shall be terminated. 
If information which proves that the 
applicant is financially eligible fs not 
received by the Department within 15 
days, financial eligibility shall be 
terminated. The applicant shall be given 
60 days from the date of the notice of 
tentative decision to terminate financial 
eligibility to fife an appeal. However. 
the The applicant may reapply for 
financial eligibility at any time if there is 
a change in family size, income, or 
deductions. 

Statutory Authority G.S. 130A-5(3); 130A-124; 
130 A- 127; 130 A- 129; 130A-205. 

.0503 EFFECT ON AUTHORIZATIONS AND 
AUTHORIZATION REQUESTS 

(a) All authorizations will be honored by the 
Department, except that an authorization may will 
be cancelled after a final deci s ion to terminate 
upon termination of financial eligibility if: 

( 1 ) The applicant and the provider are 
notified of the authorization cancellation 
prior to the provision of the service. 
Authorizations may will be cancelled in 
part when only some of the services 
have been provided; and 

(2) The provider has not made financial 
commitments based upon the authoriza- 
tion. 

(b) Authorization requests for s ervices to be 
provided after the 15 day appeal period which arc 
received — by — the — Department — after — a — tentative - 
dec is ion to terminate financial eligibil i ty and prior 
to a final decision in the matter will be held until 
a final decision is made received during the period 
of time that financial eligibility [s being investigat- 
ed will be held until a decision about termination 
of eligibility is made. If financial eligibility is 
terminated, all pending authorization requests will 
be denied. 

Statutory Authority G.S. 130A-5(3); 130A-124; 
130A-127; 130A-129; 130A-205. 

TITLE 21 - OCCUPATIONAL 
LICENSING BOARD 



2183 



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NORTH CAROLINA REGISTER 



January 4, 1993 



PROPOSED RULES 



Notice is hereby given in accordance with G.S. 
150B-21.2 that the North Carolina Board of 
Mortuary Science intends to amend rules cited as 
21 NCAC 34 A .0102 and .0201; adopt 21 NCAC 
34D .0101 - .0103, .0201 - .0202, .0301 - .0304 
and .0401 - .0404. 

1 he proposed effective date of this action is April 
I, 1993. 

1 he public hearing will be conducted at 1:00 
p.m. on February 15, 1993 at the Auditorium of 



State Highway Building, 
Street. Raleigh, NC. 



1 South Wilmington 



MXeason for Proposed Action: 
21 NCAC 34A .0102 - G.S. 90. Article 13D, has 
expanded purpose of Board to include regulation 
of sale of preneed funeral contracts. 
21 NCAC 34A .0201 - G.S. 90-210.67 directs 
Board to set fees. 

21 NCAC 34D .0101 - G.S. 90-210. 62(b) directs 
Board to approve preneed contract forms. Pro- 
posed Rule sets requirements for forms. 
21 NCAC 34D .0102 - G.S. 90-210.67(d) imposes 
per-contract fee. Board needs to make provision 
for refund of fee if contract not binding because 
insurance coverage denied. 

21 NCAC 34D .0103 - Board needs to inform 
sellers and purchasers of a typical fact situation 
under which a "preneed funeral contract" arises 
pursuant to definition in G.S. 90-210.60(5). 
21 NCAC 34D .0201 - Board needs to inform 
applicants of requirements for applications, renew- 
als and display of preneed funeral establishment 
license. 

21 NCAC 34D . 0202 - G. S. 90-210. 67(a) requires 
Board to establish qualifications for and activities- 
permitted under preneed sales license. Applicants- 
need to know application requirements. 
21 NCAC 34D .0301 - Board needs to inform 
funeral homes in what form preneed records are to 
be kept for inspection. 

21 NCAC 34D .0302 - Board needs to inform 
funeral homes of contents of annual report to be 
filed with Board. 

21 NCAC 34D .0303 - Board needs to establish 
contents of and funeral home needs to know how to 
present certificate for obtaining funds to pay for 
funeral. 

21 NCAC 34D .0304 - G.S. 90-2 10. 68(b) permits 
transfer of trust funds from one financial institution 



to another. Rule is needed for procedure, includ- 
ing use of Board form. 

21 NCAC 34D .0401 - Definitions of terms need- 
ed, as used in succeeding Rules pertaining to 
Preneed Recovery Fund. 

21 NCAC 34D . 0402 - G. S. 90-210. 66(d) requires 
Board to adopt rules governing presentation of 
applications for reimbursement from fund. 
21 NCAC 34D .0403 - G. S. 90-210. 66(d) requires 
Board to adopt rules governing processing applica- 
tions for reimbursement from fund. 
21 NCAC 34D . 0404 - G. S. 90-210. 66(d) requires 
Board to adopt rules governing subrogation as to 
reimbursements from fund. 

(comment Procedures: Interested persons may 
present statements, orally and in writing, at the 
public hearing and in writing prior to the hearing 
by mail addressed to Mr. Donald H. Carpenter, 
NC Board of Mortuary Science, Box 27368, 
Raleigh. NC 2761 1-7368. 



CHAPTER 34 



BOARD OF MORTUARY 
SCIENCE 



SUBCHAPTER 34A - BOARD FUNCTIONS 
SECTION .0100 - GENERAL PROVISIONS 

.0102 PURPOSE OF BOARD 

The purpose and function of the Board are to 
examine, license and regulate the practice of 
funeral service^ aa4 the operation of crematories 
and the sale of preneed funeral contracts in North 
Carolina, pursuant to the authority granted by 
Articles 13A A w*i 13C and 13D, Chapter 90. 
General Statutes of North Carolina. 



Statutory Authority G.S. 
210.50(a); 90-21 0.69(a). 



90-2 10. 23(a); 90- 



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2184 



PROPOSED RULES 



SECTION .0200 - FEES AND OTHER 
PAYMENTS 



0201 FEES AND PENALTIES 






(a) Fees for funeral service shall be as follows: 






Establishment permit 






Application 


$ 


250.00 


Annual renewal 


$ 


150.00 


Late renewal penalty 


$ 


100.00 


Establishment reinspection fee 


$ 100.00 


Courtesy card 






Application 


$ 


75.00 


Annual renewal 


$ 


50.00 


Out-of-state licensee 






Application 


$ 


200.00 


Embalmer, funeral director, funeral service 






Application. North Carolina resident 


$ 


150.00 


Application, non-resident 


$ 200.00 


Annual renewal 






Embalmer 


s 


40.00 


Funeral director 


$ 


40.00 


Funeral service 


$ 


60.00 


Reinstatement fee 


s 


50.00 


Resident trainee permit 






Application 


$ 


50.00 


Annual renewal 


$ 


35.00 


Late renewal penalty 


s 


25.00 


Duplicate license certificate 


$ 


25.00 


Chapel registration 






Application 


$ 


150.00 


Annual renewal 


s 


100.00 


(b) Fees for crematories shall be as follows: 






License 






Application 


S 400.00 


Annual renewal 


$ 


150.00 


Late renewal penalty 


$ 


75.00 


Crematory reinspection fee 


s 


100.00 


Per-cremation fee 


s 


5.00 


(c) Fees for preneed funeral contract regulation shall be as follows: 






Preneed funeral establishment license 






Application 


$ 


100.00 


Annual renewal 


$ 


100.00 


Preneed sales license 






Application 


$ 


10.00 


Annual renewal 


$ 


10.00 



Statutory Authority G.S. 90-210. 23(a); 90-210.28; 90-210.48; 90-210. 67(b). (c). 



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PROPOSED RULES 



SUBCHAPTER 34D - PRENEED FUNERAL 
CONTRACTS 

SECTION .0100 - GENERAL PROVISIONS 

.0101 APPROVAL OF CONTRACT 
FORMS 

No preneed funeral contract form shall be ap- 
proved by the Board unless it^ with any attach- 
ments, meets the following requirements, insofar 
as they are applicable to the lawful, intended sales 
transaction: 

( 1 ) Is written jn clear, understandable lan- 
guage and js printed in easy -to -read type, 
size and style. 

(2) States or provides space for inserting the 
name, address and preneed funeral estab- 
lishment license number of the contract- 
ing funeral establishment. 

(3) Provides space for inserting the names, 
addresses and Social Security n umbers of 
the purchaser and contract beneficiary. 

(4) Provides space for a description of the 
merchandise and services purchased. 

(5) Discloses any penalties or restrictions, 
including geographical restrictions, on 
the delivery of merchandise and services. 

(6) States whether it is a standard or infla- 
tion-proof contract and summarizes, 
consistent with North Carolina law, the 
incidents of such type of contract. 

(7) Provides space for inserting the financial 
transaction. 

(8) Provides space for the purchaser to indi- 
cate, by the purchaser's signature or 
initials, the following: 

(a) The purchaser's choice of trust-funded 
or insurance-funded contract. 

(b) That the purchaser acknowledges that 
the funeral establishment will retain, 
and not deposit in trust, a stated per- 
centage (not more than 10%) of the 
purchaser's payments. 

(c) The purchaser's choice of revocable or 
irrevocable contract. 

(d) That the purchaser acknowledges that 
the sale was made at the funeral 
establishment's place of business, so as 
to negate the cancellation rights con- 
nected with an off-premises sale. 

(9) Contains notice, jn bold type, of the 
purchaser's right to cancel an off-premis- 
es sale. 

(10) Contains notice, jn bold type, that jf tine 



ii; 



(12) 

mi 



purchaser does not receive notification 
from the Board, within 30 days, that jt 
has received a copy of the contract, the 
purchaser should notify the Board at its 
current, stated address and telephone 
number. 

Explains the parties' rights and obliga- 
tions, consistent with North Carolina law, 
with respect to contract revocation, de- 
fault, the funeral establishment's reten- 
tion of a portion of the purchase price 
free of the trust, and the substitution of 
funeral homes to perform the contract. 
Contains a notice of the existence of the 
Board's preneed recovery fund. 
Contains, or refers to an attachment 
containing, all funeral sales disclosures to 
consumers as required by federal and 
North Carolina law. 



Statutory Authority G.S. 90-21 0.69(a); 90- 
210.62(h). 

.0102 REFUND OF CONTRACT FEES 

The preneed funeral contract fee, paid as 
required by G.S. 90-210. 67(d), shall be refunded 
by the Board to the payor only jn the event that, 
because the insurance company refuses to insure 
the proposed preneed funeral contract beneficiary, 
the preneed funeral contract does not become 
binding. 

Statutory Authority G.S. 90-2 10. 69(a). 

.0103 INSURANCE-FUNDED CONTRACTS 

A "preneed funeral contract," as defined jn G.S. 
90-210.60(5). js created when any person, 
partnership, corporation or association of 
individuals engaged jn the business of providing 
funeral services or merchandise js named, with 
knowledge of being named, as a revocable or 
irrevocable beneficiary or co-beneficiary or 
assignee of a "prearrangement insurance policy." 
as defined jn GJL 90-210.60(4), regardless of 
whether specific funeral services or merchandise js 
selected. This example does not preclude the 
creation of insurance-funded preneed funeral 
contracts pursuant to other facts . 

Statutory Authority G.S. 90-210. 69(a). 



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2186 



PROPOSED RULES 



SECTION .0200 - LICENSING 

.0201 PRENEED FUNERAL 

ESTABLISHMENT LICENSE 

(a) A funeral establishment wishing to apply for 
a preneed funeral establishment license shall 
submit to the Board, m addition to the information 
required by G.S. 90-2 10.67(a). its funeral estab- 
lishment permit number issued pursuant to G.S. 
90-2 10.25(d). type of business entity, whether it is 
authorized to transact business in North Carolina, 
whether it is soh'ent. whether there exist unsatis- 
fied ci\il judgments against the applicant and 
copies of any, whether the applicant or any of its 
principals has been denied a license to engage in 
an occupation or had a license suspended, revoked 
or placed on probation, and whether any principal 
has been convicted of a crime involving fraud or 
moral turpitude. 

(b) The Board may require an applicant to 
submit additional proof to satisfy the requirements 
of G.S. 90-2 10.67(a) and (b). 

(c) The applicant shall submit, with its applica- 
tion, the names, preneed sales license numbers and 
telephone numbers of aH preneed sales licensees 
who will sell preneed funeral contracts as employ- 
ees or agents of the applicant. Any additions to or 
deletions from the list of names shall be reported 
to the Board, within 10 days of the change, as an 
amended application on an application form. 

(d) The same Board form shall be used for the 
original application, annual renewal application 
and amended application. 

(e) Preneed funeral establishment licenses shall 
not be transferable. Upon a transfer of ownership 
of a funeral establishment, the provisions of 21 
NCAC 34B .0605 apply, and a new application for 
a preneed funeral establishment license shall be 
made to the Board within 30 days of the transfer. 
The application fee shall accompany the applica- 
tion, as in the case of initial applications. 

(f) The license certificate shall be conspicuously 
displayed in the funeral establishment at the ad- 
dress to which it js issued. 

Statutory Authority G.S. 90-210.69(a); 90- 
210.67(a). (b). 

.0202 PRENEED SALES LICENSE 

fa) Subject to G.S. 90-2 10.69(c). holding a 
funeral director's license, issued by the Board, or 
a funeral service license, issued by the Board, is 
the qualification to be eligible for a preneed sales 
license. 



(b) The preneed sales licensee may engage, 
under the preneed sales license, in afj of the 
activities of "preneed funeral planning" as defined 
in OS. 90-210.60(8). No preneed funeral 
planning activities shall be engaged in by_ anyone 
other than a preneed sales licensee. No preneed 
sales license is required for solely the sale of a 
prearrangement insurance policy. 

(c) A licensed funeral director or funeral service 
licensee wishing to apply for a preneed sales 
license shall submit to the Board the applicant's 
name, address, telephone number, funeral 
director's or funeral service license number, name 
and address of the preneed funeral establishment 
licensee or licensees on whose behalf the applicant 
will sell preneed funeral contracts, and the 
applicant's employment or agency relationship with 
the licensee or licensees. If the applicant proposes 
to sell on behalf of more than one preneed funeral 
establishment licensee, the applicant shall disclose 
information to satisfy the requirement of G.S. 
90-2 10.67(a) that the preneed funeral establishment 
licensees be related by ownership or contract. 

(d) The Board shall issue to each preneed sales 
licensee a pocket card as certification of the 
preneed sales license. The preneed sales licensee 
shall carry the card while engaging in preneed 
funeral planning. The card shall indicate the 
names of the preneed funeral establishment 
licensees on whose behalf the preneed sales 
licensee is authorized to sell preneed funeral 
contracts, and if there is any change in the list of 



establishments on whose behalf the preneed sales 
licensee is authorized to sell, the preneed sales 
licensee shall make a new application for a 
preneed sales license and shall pay the application 
fee. 

Statutory Authority G.S. 90-21 0.69(a); 90- 
210.67(a). (c). 

SECTION .0300 - OPERATIONS 

.0301 RECORD AND BOOKKEEPING 
REQUIREMENTS 

(a) Each preneed funeral establishment licensee 
shall maintain at the address stated on its license a 
general file containing: 



Uj 



a copy of each of ks license 



applications, including applications for 
license renewals: 

(2) copies of a_U preneed examination 
reports; and 

(3) copies of all annual reports to the 
Board. 



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PROPOSED RULES 



(b) Each such licensee shall maintain, at the 
same address, files containing all pre need funeral 
contracts purchased. The files shall be maintained 
separately for outstanding contracts and for 
matured or cancelled contracts. The outstanding 
contract file shall include a copy of each preneed 
contract filed alphabetically or numerically. The 
matured or cancelled contract file shall contain a 
copy of each preneed contract, together with a 
copy of the certificate of performance, and shall be 
filed either chronologically or alphabetically by 
year. 

(c) Each such licensee shall maintain, at the 
same address, the following records: 

( 1) a contract register listing the 
purchaser's name and final disposition 
of the contract; 

(2) a separate cash journal or separate cash 
receipt book designated for preneed. 
showing all preneed payments 
collected; 

(3) an individual ledger for each contract 
purchaser showing the purchaser's and 
beneficiary's names, amount of the 
contract, amount paid on the contract, 
amount retained free of trust pursuant 
to G.S. 90-210. 61(a)(2). deposits to 
trust, withdrawals from trust as 
permitted by law and the reasons 
therefor, interest on deposits, total 
amount of the trust, and amounts paid 
to insurance companies for insurance- 
funded contracts; 

(4) copies of bank statements and deposit 
slips from financial institutions in which 
trust funds are deposited, certificate of 
deposit records. including both 
principal and interest transactions 
and/or trust accountings; and 

(5) copies of applications for insurance, 
insurance policies. beneficiary 
designation documents and instruments 
of assignment. 

(d) Individual ledgers and records of the 
depository financial institutions shall be balanced 
at least annually to ensure accuracy. 

Statutory Authority G.S. 90-2 10. 69(a): 90- 
210.68(a). 

.0302 ANNUAL REPORT 

Each preneed funeral establishment licensee shall 
file an annual report with the Board. The report 
shall include the following: 



inflation-proof trust-funded and insur- 
ance-funded preneed funeral contracts 
maintained by the licensee; 

(2) the number of contracts sold rn the re- 
porting period; 

(3) the number of contracts which expired, 
including contracts performed, revoked 
and transferred, in the reporting period; 

(4) the total year-end balance of aH preneed 
trust accounts maintained at each finan- 
cial institution; and 

(5) the total year-end balance of all insur- 
ance-funded preneed contracts written 
with each insurance company. 

The annual report shall be filed not later than 
March 3 1 each year for the preceding year ending 
December 31 . 

Statutory Authority G.S. 90-21 0.69(a); 90- 
210. 68(a). 

.0303 CERTIFICATE OF PERFORMANCE 

(a) The certificate of performance or similar 
claim form as required by G.S. 90-2 10.64(a) shall 
be a form as prepared by the Board and shall 
require the following information: the names, 
addresses and preneed funeral establishment 
license numbers of fhe performing funeral 
establishment and the contracting funeral 
establishment; the name of the deceased 
beneficiary of the preneed funeral contract; the 
date of death and the county where the death 
certificate was or will be filed; the invoice amount; 
certification that the contract was or was not 
performed [n whole or in part and how the funds 
will be applied; the name and address of the 
financial institution where the preneed trust funds 
are deposited and the trust account or certificate 
number; the name and address of ffie insurance 
company which issued the prearrangement 
insurance policy and the policy number; and the 
amount and the date of the payment by the 
financial institution or insurance company and to 
whom paid. 

(b) The form shall be completed by each funeral 
establishment performing any services or providing 
any merchandise pursuant to ffie preneed funeral 
contract, or. if none are performed or provided, by 
the contracting funeral establishment. The form 
shall be presented to ffie financial institution or 
insurance company for payment. Within 10 days 
following its receipt of payment, any funeral 
establishment which is required to complete the 
form shall mail a copy to the Board . 



ill 



the total number of standard and/or 



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2188 



PROPOSED RULES 



Statutory Authority G.S. 90-2 10. 69(a); 90- 
210.64(a); 90-210.68. 

.0304 TRANSFER OF TRUST FUNDS 

When, pursuant to G.S. 90-210. 68(b). a preneed 
licensee directs a transfer of preneed funds to a 
substitute financial institution, the financial institu- 
tion which js a party to the preneed funeral con- 
tract shall make the transfer directly and solely to 
the substitute financial institution and not mediately 
to the preneed licensee. The notification to the 
Board as required by G.S. 90-210. 68(b) shall be 
made on a form provided by the Board, which 
shall indicate the transfer of the funds by the 
financial institution and their acceptance by the 
substitute financial institution and the agreement of 
the substitute financial institution to be bound by 
the preneed funeral contract and, if the contract js 
revocable, certification that the licensee has noti- 
fied the purchaser of the intended transfer. 

Statutory Authority G.S. 90-21 0.69(a); 90- 
210.68(h). 



following minimum information: 

(1) The name and address of the applicant. 

(2) The name and address of the licensee 
under G.S. 90. Article 13D. who 



SECTION .0400 



PRENEED RECOVERY 
FUND 



.0401 DEFINITIONS 

For the purposes of this section, the following 
definitions shall apply: 
( 1 i "Fund" shall mean the preneed recovery 

fund as established by G.S. 90-210.66. 

(2) "Applicant" shall mean a person who has 
suffered a reimbursable loss pursuant to 
G.S. 90-210.66. 

(3) "Reimbursable losses" are only those 
losses of money which meet the require- 
ments of G.S. 90-210.66 and in which. 
as determined by the Board, the applicant 
has exhausted all viable means to collect 
the applicant's losses and has complied 
with this section. Reimbursable losses 
shall not include losses of spouses, chil- 
dren, parents, grandparents, siblings, 
partners, associates, employers and em- 
ployees of the person or business entity 
causing the losses. 

Statutory Authority G.S. 90-210. 69(a); 90- 
210.66(c). (d). (f), (g). 

.0402 APPLICATION FOR 
REIMBURSEMENT 

(a) The Board shall furnish a form of application 
for reimbursement which shall require the 



caused the alleged loss. 



ill 

(4J 
(5J 
16] 
ill 



(8i 



The amount of the alleged loss for 

which application for reimbursement is 

made. 

A copy of any preneed funeral contract 

which was the basis of the alleged loss. 

The date or period of time during 

which the loss was incurred. 

A general statement of facts relative to 

the application. 

All supporting documents, including 

copies of court proceedings and other 

papers indicating the efforts of the 

applicant to obtain reimbursement from 

the licensee, insurance companies or 

others. 

A documentation of any receipt of 

funds [n partial payment of the loss. 

(b) The application form shall contain the 
following statement in boldface type: "The North 
Carolina General Assembly in G.S. 90-210.66 
established the preneed recovery fund and directed 
the North Carolina Board of Mortuary Science to 
provide for its funding and administration. The 
establishment of the fund did not create or 
acknowledge any legal responsibility on the part of 
the Board for the acts, or failure to act, of 
persons, firms or corporations licensed by rL All 
reimbursements of losses from the fund shall be a 
matter of privilege i_n the sole discretion of the 
Board and not a matter of right. No applicant or 
member of the public shall have any right in the 
fund as a third-party beneficiary or otherwise." 

(c) An application shall he filed i_n the office of 
the Board. 

Statutory Authority G.S. 90-21 0.69(a); 90- 
210.66(a). (c), (J), (f). (g). 

.0403 PROCESSING APPLICATIONS 

(a) The Board in making investigation of all 
applications filed for reimbursement from the 
preneed recovery fund may require the attendance 
of and examine under oath all persons, including 
the alleged defalcating licensee, whose testimony 
it may require. A determination of the application 
shall be made by a majority vote of those present 
at a Board meeting at which a quorum \s_ present. 
The Board may, in its discretion, afford the 
applicant a reconsideration of the application: 
otherwise, a rejection is final, and no further 



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PROPOSED RULES 



consideration shall be given by the Board to the 
application or to another application based upon 
the same alleged facts. 

(b) No more than 50% of the amounts received 
by the fund shall be available for disbursement for 
applications until a corpus of $50,000.00 is 
created. Subject to the foregoing, the Board shall, 
in its discretion, determine the amount of loss, if 
any, for which the applicant should be reimbursed 
from the fund. In making such determination, the 
Board's considerations shall include: 

(1) The negligence, if any, of the applicant 
which contributed to the loss. 

(2) The hardship which the applicant 
suffered because of the loss. 

(3) The total amount of reimbursable losses 
of applicants on account of any one 
licensee or association of licensees. 

(4) The total amount of previous 
reimbursable losses for which total 
reimbursement has not been made and 
the total assets of the fund. 



(5) The total amount of insurance available 
to compensate the applicant for the 
loss. 

(c) The Board may, in its discretion, allow 
further reimbursements in cases in which a loss 
has not been fully reimbursed. 

(d) Before receiving a payment from the fund, 
the person who is to receive such payment or his 
or her legal representative shall execute and 
deliver to the Board a written agreement stating 
that in the event the reimbursed applicant or his or 
her estate ever receives any restitution from the 
licensee or from any other source, the reimbursed 
applicant or his or her estate shall repay the fund 
the restitution received or the amount of 
reimbursement from the fund, whichever is less. 

Statutory Authority G.S. 90-2 10.69(a); 90- 
210.66(a). (c). (d). (g). 

.0404 SUBROGATION 

In pursuing a subrogation claim as authorized by 
G.S. 90-210. 66(h), the Board may require the 
reimbursed applicant to execute a subrogation 
agreement, providing for, among other things, that 
the action may be brought in the name of the 
applicant. Upon commencement of an action by 
the Board pursuant to its subrogation rights, it 
shall notify the reimbursed applicant at hjs or her 
last known address in order that the applicant may 
join in the action if desired. Any amounts 
recovered by the Board in excess of the amount to 
which the fund is subrogated, less the Board's 



actual costs of recovery, shall be paid to or 
retained by the reimbursed applicant as the case 
may be. 

Statutory Authority G.S. 90-210. 69(a); 90- 
210. 66(d). 

TITLE 24 - INDEPENDENT AGENCIES 

iSotice is hereby given in accordance with G.S. 
150B-21.2 that the Safety and Health Review 
Board of North Carolina intends to amend rules 
cited as 24 NCAC 3 .0505 - .0506. .0602. 

1 he proposed effective date of this action is April 
1. 1993. 

1 he public hearing will be conducted at 10:00 
a.m. on February 15. 1993 at the N. C. State Bar 
Building. Council Chambers - 3rd Floor. 208 
Fayetteville Street Mall. Raleigh. N.C 

ixeasonfor Proposed Action; Tlie purpose of the 
amendments to the rules are to: allow 
cross-appeals; define responsibilities for ordering 
transcripts and for sharing the cost of transcripts 
between cross-appellant; define time periods for 
filing briefs and the format of briefs for 
cross-appellants and to allow friend-of-the-court 
briefs. 

KsOmment Procedures: Anyone wishing to 
comment on these proposed amendments to the 
rules should send comments to Doris Hinton at 121 
West Jones Street, Raleigh. NC 27603 by February 
12. 1993. 

CHAPTER 3 - SAFETY AND HEALTH 
REVIEW BOARD OF NORTH CAROLINA 

SECTION .0500 - HEARINGS 

.0505 COURT REPORTERS: FEES: COST 
OF TRANSCRIPT OF TESTIMONY 

(a) The court reporter's fees and the cost of the 
original transcript of testimony for depositions as 
provided in Rules .0504 and .051 1 of this Section, 
shall be borne by the party which arranges for the 
reporter's appearance and each person who desires 
a copy of the transcript will be responsible for 
securing it and for its cost. 

(b) In cases where no appeal has been effected. 



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2190 



PROPOSED RULES 



the Review Board will arrange for and pay for the 
private court reporter's fees for each hearing. If 
a transcript is ordered by the hearing examiner or 
Board and no appeal has been effected, or if the 
Board directs review, the Board will also pay for 
preparation of the original transcript and persons 
desiring a copy of the transcript will be 
responsible for securing it and for its cost. 

(c) If an appeal is effected a petition for review 
js filed , the court reporter's fees, cost of the 
original transcript, one copy for the Board, and 
©fte copy for the appellant will be paid for by the 
appellant and other persons desiring a copy of the 
transcript will be responsible for securing it and 
for its cost. If a cross-petition for review is filed. 
the cross-petitioner shall reimburse the petitioner 
for one-third of the cost of the court reporter's 
fees, original transcript, and copy for the Board. 

Statutory Authority G.S. 95-135. 

.0506 TRANSCRIPT OF TESTIMONY 

(a) Hearings, including testimony and argument 
(on request) shall be transcribed verbatim. After 
a dec i sion — has — been — rendered — by — the — hearing 
examiner and appeal ha s been taken, three copies 
of the transcript of te s timony taken at the hearing, 
dulv certified by the reporter, shall be filed with 
the Board. If review is directed by the Board, the 
Board will order the transcript and notify the 
parties when it is filed with the Board. If a 
petition for review is filed, the petitioner shall, at 
the time of filing, order the transcript and ensure 
that one copy is filed with the Board. The Board 
will notify parties when the transcript is filed with 
the Board. 

(b) The public proceedings conducted by the 
Review Board and by its hearing examiners may 
be recorded by an audio-tape recorder by any 
person in attendance. The Chairman of the 
Review Board, or the hearing examiner shall 
control the manner of any tape recording process 
to ensure that it is not disruptive to the proceeding. 

(c) Should it become impossible or extremely 
impractical for the court reporter to prepare a 
transcript of the evidence because of mechanical 
failure, loss or destruction of tapes or notes, or for 
any other reason, it shall become the duty of the 
parties to prepare a summary of evidence from 
their trial notes and best recollection. The 
prevailing party, or the party designated by the 
hearing examiner, shall have 30 days from the date 
notice is sent to him by the hearing examiner or 
the Review Board in which to prepare and serve 
upon opposing party his proposed summary of 



evidence. The opposing party shall review it and 
if he disagrees with any portion thereof, or 
believes that the summary is not complete, he shall 
have 20 days in which to serve upon the prevailing 
party any proposed revisions, including any 
deletions and additions. If the prevailing party 
agrees to such revisions, the two parties shall sign 
a certification that the summary of evidence is 
agreed by them to accurately reflect the substance 
of the testimony and other evidence presented at 
the hearing. If the parties cannot agree, their 
respective versions of the summary shall be 
submitted to the hearing examiner and he or she 
shall review the proposals, together with the 
hearing examiner's trial notes, and thereafter enter 
a ruling as to what constitutes the summary of 
evidence, which shall thereafter be treated for all 
purposes as the transcript of the proceedings. 

(d) Errors in the transcript of the hearing may 
be corrected by the hearing examiner on his own 
motion, or on the motion of a party. Each 
correction will be made by hand with pen and ink 
and initialed by the hearing examiner, or the 
hearing examiner may sign and attach an errata 
sheet. 

Statutory Authority G.S. 95-135. 

SECTION .0600 - POST HEARING 
PROCEDURES 

.0602 REVIEW: BRIEFS FOR REVIEW 

(a) Petitioning for review. Any member of the 
Board may direct that a decision of a hearing 
examiner be reviewed by the entire Board as a 
whole. Any party may reque s t review within 30 
day s , adversely affected or aggrieved by the 
decision of ffie hearing examiner (pursuant to Rule 
.0309 or 0601 of this Chapter) or by the decision 
of the Chairman of the Review Board (pursuant to 
Rule .0309 of this Chapter) may file a petition for 
review. The petitioner or cross-petitioner must 
comply with applicable Rules .0505 and .0506 of 
this Chapter. If no direction for review or request 
petition for review is given effected within 30 days 
ef from the filing of the hearing examiner's order 
whh — the — Board, date on which the hearing 
examiner's or Chairman's decision is filed with the 
Board, such order decision shall become a fhe final 
order of the Review Board. A petition for review 
or cross-petition for review may be conditional: 
either may state that review is sought only upon 
the existence of an opposing party's petition for 
review. A cross-petition for review may be filed 
within seven days of notice from the opposing 



2191 



7:19 



NORTH CAROLINA REGISTER 



January 4, 1993 



PROPOSED RULES 



party of its petition for review. 

(b) Content of the petition. A petition for 
review or cross-petition for review shall concisely 
and precisely state the portion(s) of the decision 
for which review is sought; refer to the citations 
and citation items (for example. Citation 1, Item 3) 
for which review is sought; identify by number 
any fact or conclusion set forth by the hearing 
examiner which is not supported by a 
preponderance of the evidence or which is 
contended to constitute an error of law; and 
identify any error contended to be prejudicial or 
any instance which is contended to be an abuse of 
discretion. 

(c) Procedure; briefs. A petition for review^ or 
cross-petition for review, timely filed, shall be 
deemed granted upon receipt by the Review Board. 
All interested parties to the original hearing shall 
be notified of the date and the time and place of 
such hearing and shall be allowed to appear in 
person or by representative as previously defined. 
Parties on appeal to the Review Board shall file a 
brief of reasons and supporting authorities relied 
on. Failure to file a brief may result in judgment 
against the parties for failure to comply with these 
Rules, the original and three copies of the brief 
shall be filed with the Board. A party shall, prior 
to the statement of facts, designate in his brief 
those pages of the transcript relevant to each 
portion of the decision and order of the hearing 
examiner to which exception is taken. The 
purpose of this Rule is to require parties to notify 
the Review Board of any pages or parts of the 
transcript which are irrelevant to the decision 
before the Review Board, as well as to notify the 
Review Board of those pages and parts of the 
transcript which are relevant. A cross-petitioner 
shall file a single brief divided into two distinct 
sections: the first section shall respond to the 
petitioner's brief; the second section shall set forth 
issues on cross-appeal in accordance with this 
Rule. A petitioner's reply brief shall be limited to 
the issues raised in the second section of the 
cross-petitioner's brief. 

(1) When review is directed by the Board, 
the Commissioner of Labor shall file 
the first brief within 30 days after being 
notified by the Board that the transcript 
of the hearing has been filed with the 
Board . Any opposing party shall then 
file its brief within 30 days of service 
of the Commissioner's brief. 

(2) If a petition for review js filed, the 
petitioning party shall file the first brief 
within 30 days of being notified by the 



Board that the transcript of the hearing 
has been filed with the Board . Any 
opposing party, including a 
cross-petitioner, shall file its brief 
within 30 days of service of the 
petitioning party's brief. 

(3) If a cross-petition for review is filed, 
the petitioner for review shall file any 
reply brief within 15 days of service of 
the cross-petitioner's brief. 

(4) If a petition for interlocutory review is 
filed and the hearing examiner or Board 
permits or orders the filing of briefs, 
the first brief must be filed by the 
petitioner within 15 days of notice that 
review is granted. Any opposing party 
shall file its brief within 15 days of 
service of the petitioning party's brief. 

(5) The brief of an amicus curiae may be 
filed only by leave of the Review Board 
Chairman. The motion for leave shall 
identify the interest of the applicant and 
shall state the reasons why a brief of an 
amicus curiae is desirable. Any amicus 
curiae shall file its brief within the time 
allowed the party whose position the 
amicus will support. 

Normally, review will be strictly limited to issues 
raised in the petition for review and cross-petition 
for review , or, if review is directed by the Board, 
review will normally be limited to issues upon 
which the hearing examiner passed judgment. 

(d) Upon review of any decision of a hearing 
examiner, the Board may adopt, modify, or vacate 
the decision of the hearing examiner and notify the 
interested parties. The report, decision, or 
determination of the Board upon review shall be 
final unless further appeal is made to the court as 
provided in Rule .0605 of this Section. 

Statutory Authority G.S. 95-135. 



7:19 



NORTH CAROLINA REGISTER 



January 4, 1993 



2192 



RRC OBJECTIONS 



1 he Rules Review Commission (RRC) objected to the following rules in accordance with G.S. 
143B-30.2(c). State agencies are required to respond to RRC as provided in G.S. 143B-30.2(d). 



ADMINISTRATION 

Motor Fleet Management Division 

1 NCAC 38 .0205 - Accident Reporting 

Agency Revised Rule 

AGRICULTURE 

Structural Pest Control Division 

2 NCAC 34 .0406 - Spill Control 

Agency Responded 
Agency Revised Rule 

2 NCAC 34 .0603 - Waivers- 
Agency Responded 
Agency Revised Rule 

2 NCAC 34 .0902 - Financial Responsibility 
Agency Responded 
Agency Revised Rule 

ECONOMIC AND COMMUNITY DEVELOPMENT 

Banking Commission 

4 NCAC 3E .0201 - Operation of other Business in same Office 
Agency Revised Rule 

Community Assistance 

4 NCAC 19S .0101 - Overview and Purpose 

Agency Revised Rule 
4 NCAC 19S .0102 - Definition 

Agency Revised Rule 
4 NCAC 19S .0103 - Waiver 

Agency Revised Rule 
4 NCAC 19S .0202 - Prohibited Costs 

Agency Revised Rule 
4 NCAC 19S .0401 - Distribution of Funds 

Agency Revised Rule 
4 NCAC 19S .1101 - Grant Agreement 

Agency Revised Rule 

Departmental Rules 

4 NCAC IK .0103 - Eligible Applicants 

4 NCAC IK .0204 - Discretionary Public Hearing by the Department 



RRC Objection 
Obj. Removed 



RRC Objection 
No Action 
Obj. Removed 
RRC Objection 
No Action 
Obj. Removed 
RRC Objection 
No Action 
Obj. Removed 



RRC Objection 
Obj. Removed 



RRC Objection 
Obj. Removed 
RRC Objection 
Obj. Removed 
RRC Objection 
Obj. Removed 
RRC Objection 
Obj. Removed 
RRC Objection 
Obj. Removed 
RRC Objection 
Obj. Removed 



RRC Objection 
RRC Objection 



09/1 7/92 
10/15/92 



07/16/92 
08/20/92 
10/15/92 
07/16/92 
08/20/92 
10/15/92 
07/16/92 
08/20/92 
10/15/92 



11/19/92 
11/19/92 



10/15/92 
11/19/92 
10/15/92 
11/19/92 
10/15/92 
11/19/92 
10/15/92 
11/19/92 
10/15/92 
11/19/92 
10/15/92 
10/15/92 



11/19/92 
11/19/92 



2193 



7:19 



NORTH CAROLINA REGISTER 



January 4, 1993 



RRC OBJECTIONS 



4 NCAC IK .0205 - Formal Application Procedures: Approval 
4 NCAC IK .0206 - Formal Application Procedures: Denial 
4 NCAC IK .0207 - Reimbursement of Extraordinary Expense 
4 NCAC IK .0302 - Criteria for Making Necessary Findings 

ENVIRONMENT. HEALTH, AND NATURAL RESOURCES 

Coastal Management 

15A NCAC 7H .0308 - Specific Use Standards for Ocean Hazard Areas 

Departmental Rules 

15A NCAC U .0204 - Loans from Emergency Revolving Loan Accounts 

15A NCAC U .0302 - General Provisions 

15A NCAC U .0701 - Public Necessity: Health: Safety and Welfare 

Environmental Management 

15 A NCAC 2B .0216 - Outstanding Resource Waters 

Agency Revised Rule 
15 A NCAC 2H .0801 - Purpose 

Agency Revised Rule 
15 A NCAC 2H .0803 - Definitions 

Agency Revised Rule 
15A NCAC 2H .0805 - Certification and Renewal of Certification 

Agency Revised Rule 

Rule Returned to Agency 
15A NCAC 2L .0107 - Compliance Boundary 

Agency Revised Rule 
15 A NCAC 20 .0302 - Self Insurance 

Wildlife Resources and Water Safety 

15A NCAC 101 .0001 - Definitions 
Agency Responded 

HUMAN RESOURCES 

Facility Services 

10 NCAC 3R .3001 - Certificate of Need Review Categories 
Agency Revised Rule 

Individual and Family Support 

10 NCAC 42C .3601 - Administrative Penalty Determination Process 

Agency Revised Rule 
10 NCAC 42T .0001 - Definitions 

Agency Revised Rule 
10 NCAC 42T .0006 - Service Delivery 

Agency Revised Rule 

Agency Revised Rule 

Mental Health: General 



RRC Objection 11/19/92 

RR C Objection 1 1 II 9/92 

RR C Objection 1 1/1 9/92 

RR C Objection 11/1 9/92 



RRC Objection 11/19/92 



RRC Objection 06/18/92 
RRC Objection 06/18/92 
RRC Objection 06/18/92 



RRC Objection 
Obj. Removed 
RRC Objection 
Obj. Removed 
RRC Objection 
Obj. Removed 
RRC Objection 
RRC Objection 

RRC Objection 
Obj. Removed 
RRC Objection 



RRC Objection 

No Action 



RRC Objection 
Obj. Removed 



RRC Objection 
Obj. Removed 
RRC Objection 
Obj. Removed 
RRC Objection 
RRC Objection 
Obj. Removed 



1 1/19/92 
11/19/92 
10/15/92 
10/15/92 
10/15/92 
10/15/92 
10/15/92 
10/15/92 
11/19/92 
10/15/92 
10/15/92 
06/18/92 



10/15/92 
11/19/92 



10/15/92 
10/15/92 



10/15/92 
10/15/92 
10/15/92 
10/15/92 
10/15/92 
10/15/92 
11/19/92 



7:19 



NORTH CAROLINA REGISTER 



January 4, 1993 



2194 



RRC OBJECTIONS 



10 NCAC 14C .1115- Funding Group Homes for Mentally Retarded Adults RRC Objection 08/20/92 

Agency Revised Rule Obj. Removed 10/15/92 

10 NCAC 14K .0216 - Waiver of Licensure Rules RRC Objection 10/15/92 

Agency Revised Rule Obj. Removed 10/15/92 

10 NCAC 14T .0101 - Scope RRC Objection 10/15/92 

Agency Revised Rule Obj. Removed 10/15/92 

10 NCAC 14T . 0103 - Advance Care Directives RRC Objection 10/15/92 

Agency Revised Rule Obj. Removed 10/15/92 



Mental Health: Other Programs 



10 NCAC 18A .0125 - Definitions 

Agency Revised Rule 
10 NCAC 18A .0132 - Decertification 

Agency Revised Rule 
10 NCAC 18D .0117 - Purpose and Scope 

Agency Revised Rule 



RRC Objection 
Obj. Removed 
RRC Objection 
Obj. Removed 
RRC Objection 
Obj. Removed 



11/19/92 
11/19/92 
11/19/92 
11/19/92 
10/15/92 
10/15/92 



INDEPENDENT AGENCIES 



N.C. Housing Finance Agency 



24 NCAC 1M .0202 - Eligibility 



No Response fror. 
24 NCAC 1M .0204 

No Response fror 
24 NCAC 1M .0205 

No Response fror 
24 NCAC 1M .0206 

No Response fror 
24 NCAC 1M .0301 

No Response frot 
24 NCAC 1M .0302 

No Response frot 
24 NCAC 1M .0303 

No Response frot 
24 NCAC 1M .0306 

No R esp ons e fror 
24 NCAC 1M .0401 

No Response frot 
24 NCAC 1M .0402 

No Response frot 
24 NCAC 1M .0403 

No Response frot 
24 NCAC 1M .0404 

No Response frot 
24 NCAC 1M .0405 



n Agency 
Selei Hon Proc edures 

n Agency 
Administration 

n Agency 
Program Fees 

n Agency 
Goal and Objectives 

n Agency 
Elig ibility R eq u irem en ts 

n Agency 
Threshold Review Criteria 

n Agency 
Funding Commitment 

n Agency- 
Goals and Objectives 

n Agency- 
Eligibility Requirements 

n Agency 
Threshold Review Criteria 

n Agency- 
Ranking Criteria 

?i Agency 
Agency Board Approval 

n Agency 



No Response frot 
24 NCAC lO .0101 - Purpose 

Agency Revised Rule 
24 NCAC lO .0102 - Eligibility 

Agency Revised Rule 
24 NCAC lO .0201 - Application Procedures 

Agency Revised Rule 
24 NCAC lO .0202 - Selection Procedures 



RRC Objection 
No Action 
RRC Objection 
No Action 
RRC Objection 
No Action 
RRC Objection 
No Action 
RRC Objection 
No Action 
RRC Objection 
No Action 
RRC Objection 
No Action 
RRC Objection 
No Action 
RRC Objection 
No Action 
RRC Objection 
No Action 
RRC Objection 
No Action 
RRC Objection 
No Action 
RRC Objection 
No Action 
RRC Objection 
Obj. Removed 
RRC Objection 
Obj. Removed 
RRC Objection 
Obj. Removed 
RRC Objection 



10/15/92 
11/19/92 
10/15/92 
11/19/92 
10/15/92 
11/19/92 
10/15/92 
11/19/92 
10/15/92 
11/19/92 
10/15/92 
11/19/92 
10/15/92 
11/19/92 
10/15/92 
11/19/92 
10/15/92 
11/19/92 
10/15/92 
11/19/92 
10/15/92 
11/19/92 
10/15/92 
11/19/92 
10/15/92 
11/19/92 
10/15/92 
11/19/92 
10/15/92 
11/19/92 
10/15/92 
11/19/92 
10/15/92 



2195 



7:19 



NORTH CAROLINA REGISTER 



January 4, 1993 



RRC OBJECTIONS 



Agency Revised Rule 
24 NCAC W .0203 - Administration 
Agency Revised Rule 

INSURANCE 

Financial Evaluation Division 

11 NCAC 11 A .0602 - Licensure 

Agency Revised Rule 

Multiple Employer Welfare Arrangements 

// NCAC 18 .0019 - Description of Forms 

Seniors' Health Insurance Information Program 

// NCAC 17 .0005 - SHI IP Inquiries to Insurers and Agents 

JUSTICE 

General Statutes Commission 

12 NCAC 8 .0506 - Declaratory Rulings 

Agency Revised Rule 

LABOR 

Occupational Safety and Health Act 

13 NCAC 7 C .0108 - Building Code 

Rule Returned to Agency 
Agency Filed Rule with OAH 
13 NCAC 7 C .0109 - Fire Prevention Code 
Rule Returned to Agency 
Agency Filed Rule with OAH 

LICENSING BOARDS AND COMMISSIONS 

Architecture 

21 NCAC 2 .0108- Fees 
Agency Revised Rule 

Cosmetic Art Examiners 

21 NCAC 14L .0301 - Applicants Licensed as Teachers in Other States 
21 NCAC 14L .0302 - Requirements for Obtaining a Teacher's License 

Dietetics/Nutrition 

21 NCAC 17 .0016 - Violations. Complaints. Subsc/nt Board Action, <& Hearings 
Agency Revised Rule 

Professional Engineers and Land Surveyors 



Obj. Removed 
RRC Objection 
Obj. Removed 



11/19/92 
10/15/92 
11/19/92 



RRC Objection 
RRC Objection 



11/19/92 
11/19/92 



RRC Objection 06/18/92 



RRC Objection 06/1 8/92 



RRC Objection 
Obj. Removed 



10/15/92 
11/19/92 



RRC Objection 

Effi 
RRC Objection 

Effi 



09/1 7/92 
10/15/92 
10/22/92 
09/17/92 
10/15/92 
10/22/92 



RRC Objection 
Obj. Removed 



RRC Objection 
RRC Objection 



RRC Objection 
Obj. Removed 



11/19/92 
11/19/92 



11/19/92 
11/19/92 



11/19/92 
11/19/92 



7:19 



NORTH CAROLINA REGISTER 



January 4, 1993 



2196 



RRC OBJECTIONS 



21 NCAC 56 .0501 - Requirement for Licensing 

Agency Revised Rule 
21 NCAC 56 .0502 - Application Procedure: Individual 

Agency Revised Rule 
21 NCAC 56 .0701 - Rules of Professional Conduct 

Agency Revised Rule 
21 NCAC 56 .1603 - Classification of Surveys 

Agency Revised Rule 
21 NCAC 56 .1604 - Mapping Requirements 

Agency Revised Rule 
21 NCAC 56 .1605 - Classification of Topographic Surveys 

Agency Revised Rule 

PUBLIC EDUCATION 

Elementary and Secondary Education 



RRC Objection 


10/15/92 


Obj. Removed 


10/15/92 


RRC Objection 


10/15/92 


Obj. Removed 


10/15/92 


RRC Objection 


10/15/92 


Obj. Removed 


10/15/92 


RRC Objection 


10/15/92 


Obj. Removed 


10/15/92 


RRC Objection 


10/15/92 


Obj. Removed 


10/15/92 


RRC Objection 


10/15/92 


Obj. Removed 


10/15/92 



16 NCAC 6C .0206 - Consortium-Based Programs 
Agency Revised Rule 



RRC Objection 
Obj. Removed 



11/19/92 
11/19/92 



REVENUE 

Individual Income. Inheritance and Gift Tax Division 



17 NCAC 3B .0401 - Penalties 
17 NCAC 3B .0402 - Interest 



RRC Objection 08/20/92 
RRC Objection 08/20/92 



Individual Income Tax Division 



/ 7 NCAC 6B . 0107 - Extensions 

17 NCAC 6B .0115 - Additions to Federal Taxable Income 

17 NCAC 6B .01 16 - Deductions from Federal Taxable Income 

17 NCAC 6B .0117 - Transitional Adjustments 

17 NCAC 6B .3406 - Refunds 



RRC Objection 08/20/92 

RRC Objection 08/20/92 

RRC Objection 08/20/92 

RRC Objection 08/20/92 

RRC Objection 08/20/92 



TRANSPORTATION 

Division of Highways 



19A NCAC 2B .0164 - Use of Right of Way Consultants- 
Agency Revised Rule 

19A NCAC2B .0165 - Asbestos Contracts with Private Firms 
Agency Revised Rule 



RRC Objection 09/17/92 

Obj. Removed 10/15/92 

RRC Objection 08/20/92 

Obj. Removed 10/15/92 



2197 



7:19 



NORTH CAROLINA REGISTER 



January 4, 1993 



RULES INVALIDATED BY JUDICIAL DECISION 



A his Section of the Register lists the recent decisions issued by the North Carolina Supreme Court, 
Court of Appeals, Superior Court (when available), and the Office of Administrative Hearings which 
invalidate a rule in the North Carolina Administrative Code. 



1 NCAC 5 A .0010 - ADMINISTRATIVE PROCEDURES 

Thomas R. West, Administrative Law Judge with the Office of Administrative Hearings, declared two portions 
of Rule 1 NCAC 5 A .0010 void as applied in Stauffer Information Systems, Petitioner v. Tlie North Carolina 
Department of Community Colleges and T)w North Carolina Department of Administration, Respondent and 
Tite University of Southern California, Intervenor-Respondent (92 DOA 0666). 

15A NCAC 19A .0202(d)(10) - CONTROL MEASURES - HIV 

Brenda B. Becton, Administrative Law Judge with the Office of Administrative Hearings, declared Rule 15A 
NCAC 19A .0202(d)(10) void as applied in ACT-UP TRIANGLE (AIDS Coalition to Unleash Power Triangle), 
Steven Harris, and John Doe, Petitioners v. Commission for Health Services of the State of North Carolina, 
Ron Levine, as Assistant Secretary of Health and State Health Director for the Department of Environment, 
Health, and Natural Resources of the State of North Carolina, William Cobey, as Secretary of the Department 
of Environment. Health, and Natural Resources of the State of North Carolina, Dr. Rebecca Meriwether, as 
Chief, Communicable Disease Control Section of the North Carolina Department of Environment, Health, and 
Natural Resources, Wayne Babbitt Jr. , as Chief of the HIV/STD Control Branch of the North Carolina 
Department of Environment, Health, and Natural Resources, Respondents (91 EHR 0818). 



7:19 NORTH CAROLINA REGISTER January 4, 1993 2198 



CONTESTED CASE DECISIONS 



1 his Section contains the full text of some of the more significant Administrative Law Judge decisions 
along with an index to all recent contested cases decisions which are filed under North Carolina's 
Administrative Procedure Act. Copies of the decisions listed in the index and not published are available 
upon request for a minimal charge by contacting the Office of Administrative Hearings, (919) 733-2698. 



KEY TO CASE CODES 



ABC Alcoholic Beverage Control Commission DST 

BDA Board of Dental Examiners EDC 

BME Board of Medical Examiners EHR 

BMS Board of Mortuary Science 

BOG Board of Geologists ESC 

BON Board of Nursing HAF 

BOO Board of Opticians HRC 

CFA Commission for Auctioneers IND 

COM Department of Economic and Community INS 

Development LBC 

CPS Department of Crime Control and Public Safety MLK. 

CSE Child Support Enforcement NHA 

DAG Department of Agriculture OAH 

DCC Department of Community Colleges OSP 

DCR Department of Cultural Resources PHC 

DCS Distribution Child Support 

DHR Department of Human Resources POD 

DOA Department of Administration SOS 

DOJ Department of Justice SPA 

DOL Department of Labor 

DSA Department of State Auditor WRC 



Department of State Treasurer 
Department of Public Instruction 
Department of Environment, Health, and 
Natural Resources 
Employment Security Commission 
Hearing Aid Dealers and Fitters Board 
Human Relations Committee 
Independent Agencies 
Department of Insurance 
Licensing Board for Contractors 
Milk Commission 

Board of Nursing Home Administrators 
Office of Administrative Hearings 
Office of State Personnel 
Board of Plumbing and Heating 
Contractors 

Board of Podiatry Examiners 
Department of Secretary of State 
Board of Examiners of Speech and Language 
Pathologists and Audiologists 
Wildlife Resources Commission 



CASE NAME 


CASE 
NUMBER 


ALJ 


FILED 
DATE 


Sandra C. Walker 

v. 

Department of Human Resources. Murdoch Center 


90 OSP 0254 


Nesnow 


12/02/92 


Donald W. Osborne 

v. 

North Carolina State University 


9 1 OSP 0556 


Becton 


12/02/92 


Bettie G. Person 

v. 

DHR, Division of Social Services. CSE 


91 CSE 1181 


Morgan 


12/10/92 


Anthony I. Somme 

v. 

DHR, Division of Social Services. CSE 


91 CSE 1246 


Mann 


12/14/92 



2199 



7:19 



NORTH CAROLINA REGISTER 



January 4, 1993 



CONTESTED CASE DECISIONS 



CASE NAME 


CASE 
NUMBER 


ALJ 


FILED 
DATE 


Todd C. Snead 

v. 

DHR, Division of Social Services, CSE 


91 CSE 1290 


Morrison 


12/10/92 


Steve Andrew Sloan 

v. 

DHR, Division of Social Services, CSE 


92 CSE 0020 


Gray 


12/10/92 


Jeanette Sheppard 

v. 

DHR, East Carolina University 


92 OSP0416 


Morgan 


12/08/92 


Alonza Mitchell t/a Flavor, 
5307 Market St.. Wilmington, NC 28405 

v. 
Alcoholic Beverage Control Commission 


92 ABC 0496 


Mann 


12/11/92 


Brenda Bowers, Bowers Day Care #2 

v. 

DHR, Day Care Section 


92 DHR 0603 


Mann 


12/02/92 


John L. Bess 

v. 

DHR, Division of Social Services, CSE 


92 CSE 0609 


Reilly 


12/14/92 


Sylvia S. Pinyan DI# 00962/SSN 107-20-6984 

v. 

Bd of Trustees of the Teachers' & St Emp Retirement Sys 


92 DST 0686 


Mann 


12/07/92 


Gerlene Locklear (Brayboy) 

v. 

DHR, Division of Social Services, CSE 


92 DCS 0751 


Nesnow 


12/07/92 


Alcoholic Beverage Control Commission 

v. 
Calvin Shackleford, T/A Shack's Place 


92 ABC 0777 


Gray 


12/15/92 


Britthaven. Inc. d/b/a Britthaven of Charlotte 

v. 

DHR, Division of Facility Services, Licensure Section 


92 DHR 0853 


Morrison 


1 2/09/92 


Anthony Dwayne Turman 

v. 

N.C. Private Protection 


92 DOJ 1048 


West 


12/14/92 



7:79 



NORTH CAROLINA REGISTER 



January 4, 1993 



2200 



CONTESTED CASE DECISIONS 



STATE OF NORTH CAROLINA 



COUNTY OF FORSYTH 



IN THE OFFICE OF 

ADMrNlSTRATTVE HEARINGS 

92 DST 0686 



i 



SYLVIA S. PINY AN. 

DI# 00962/SSN 107-20-6984. 
Petitioner. 



THE BOARD OF TRUSTEES OF THE 
TEACHERS' AND STATE EMPLOYEES" 
RETIREMENT SYSTEM. 

Respondent. 



RECOMMENDED DECISION 



This contested case was heard before Julian Mann. Ill, Chief Administrative Law Judge, on October 
26. 1992. in the New County Building. Washington Courtroom, High Point, North Carolina. 



For Petitioner: 



For Respondent: 



For Petitioner: 
For Respondent: 

For Petitioner: 
For Respondent: 



APPEARANCES 

Sylvia S. Pinyan 
4447 Thomasville Road 
Winston-Salem, North Carolina 27107 
Petitioner - Pro Se 

Alexander McC. Peters 

Associate Attorney General 

N. C. Department of Justice 

P.O. Box 629 

Raleigh. North Carolina 27602-0629 

Attorney for Respondent 

WITNESSES 

Sylvia S. Pinyan. Petitioner 
J. Marshall Barnes. Ill 

EXHIBITS 
Petitioner's Exhibit #1. 2 
Respondent's Exhibit #1, 2, 3 and 4 
ISSUE 



I 



Whether or not Respondent acted improperly or otherwise than as required by law in offsetting 
Petitioner's benefits from the disability income plan? 

Based upon the greater weight of the admissible evidence, the undersigned makes the following: 



2201 



7:19 



NORTH CAROLINA REGISTER 



January 4, 1993 



CONTESTED CASE DECISIONS 



FINDINGS OF FACT 

1 . The Office of Administrative Hearings has jurisdiction over this contested case pursuant to 
Chapters 135 and I50B of the North Carolina General Statutes. 

2. The Petitioner is a citizen and resident of Forsyth County, North Carolina. 

3. The Petitioner was previously employed by the Davidson County Schools as a learning 
disabled/emotionally handicapped teacher. 

4. The Petitioner was placed on long term disability by Respondent's medical board effective 
August 7, 1990. 

5. At all times relevant herein. Petitioner was eligible to receive federal Social Security 
retirement benefits from the Social Security Administration. 

6. On or about October 30, 1991, Respondent received an Attorney General's opinion authored 
by Norma S. Harrell. as to the correct interpretation of G.S. 1 35- 106(b) . Ms. Harrell interprets for the 
Respondent the following: (Respondent's Exhibit #1) 

"...the test is not whether the individual is actually receiving the social security 
benefit. It is whether he could or would be entitled to it. Therefore, a person who is age 
62 and eligible for a primary social security benefit must have his disability benefit reduced 
by the amount of the primary social security benefit to which he would be entitled, regardless 
of whether he has actually applied for received the social security benefit." 

7. Based upon the Attorney General's opinion, on or about December 10, 1991, Respondent 
notified Petitioner of its intention to offset Petitioner's benefits as follows: (Respondent's Exhibit #2) 

"Our records indicate that you have attained 62 years of age. however, at present our 
records do not indicate that you are in receipt of social security benefits. Therefore, it will 
be necessary for you to provide us a Statement from the Social Security Administration as 
to the amount of social security benefit you would have been entitled to receive at age 62." 

8. Upon receipt of the foregoing correspondence. Petitioner, who was at all times eligible to 
receive the long term retirement benefit from the Social Security Administration, applied for social security 
retirement benefits. Petitioner began to receive the benefit from the Federal Social Security Retirement 
System in March. 1992. 

9. On or about March 4. 1992, the Respondent notified the Petitioner of Respondent's intention 
to recoup $655.00: (Correspondence - Respondent's Exhibit #3) 

"Based on information you have provided, we have determined that your long- term 
disability benefits should have been reduced by the age 62 social security benefit you would 
be entitled to receive. We have estimated that, effective January 1 . 1992, your benefit should 
have been offset by $655.00. As your benefits were not reduced by the social security until 
February, 1992, we have determined that you have been overpaid long-term disability 
benefits in the amount of $655.00. 

The provisions of the plan require you to refund any overpayments. Therefore, you 
should forward your check or money order as soon as possible for $655.00 to the North 
Carolina Employee Disability Fund in care of the Department of State Treasurer, 325 North 
Salisbury Street, Albemarle Building, Raleigh, North Carolina 27603-1388." 

10. On or about April 13, 1992, Respondent notified Petitioner of Respondent's intention to 
recoup overpayment in monthly installments by correspondence quoted in part: (Respondent's Exhibit #3) 



7:19 NORTH CAROLINA REGISTER January 4, 1993 2202 



CONTESTED CASE DECISIONS 



"Per our agreement, we will begin deducting $72.78 from your monthly benefit in 
repayment of your outstanding balance. This deduction will begin with your benefit due 
April 24. 1992 and will continue for approximately 9 months. No interest will be charged 
on your outstanding balance." 

I 1 . Petitioner filed her contested case to dispute the Respondent's actions in making deductions 

from her State Retirement Disability Income but did not dispute Respondent's interpretation of G.S. 135- 
106(b) as to the setoff of benefits. 

Based on the foregoing Findings of Fact, the undersigned Chief Administrative Law Judge makes the 
following: 

CONCLUSIONS OF LAW 



1 . The Office of Administrative Hearings has jurisdiction over this contested case pursuant to 
Chapters 135 and 150B of the North Carolina General Statutes. 

2. That at all times relevant herein. Petitioner was eligible to receive a primary Social Security 
Retirement benefit. 

3. At all times relevant hereto, the Petitioner was receiving from Respondent a long term 
disability benefit pursuant to G.S. 135-106. 

4. G.S. 135- 106(b) mandates that Petitioner's long term disability benefit be reduced "by an 
amount, as determined by the Board of Trustees, equal to a primary' Social Security retirement benefit to 

which the beneficiary might be entitled . " (emphasis added) 

5. Inasmuch as the Petitioner received from the Respondent a long term retirement disability 
benefit which was not setoff by Petitioner's Social Security retirement benefit for which she was eligible to 
receive, Respondent was entitled to seek a refund from the Petitioner in the amount of the overpayment. 

6. Petitioner was advised of Respondent's intention to reduce Petitioner's benefit by way of 
correspondence mailed directly to Petitioner on or about December 10. 1991. Although the notice of the 
intention to terminate the benefits was brief. Petitioner was presented the opportunity to contest the 
determination by contacting the Member Services Section at the telephone number listed. Petitioner was 
accorded pre-termination procedural due process.* 

Inasmuch as Petitioner was given an opportunity to file a contested case to contest the 
reduction of benefits through a hearing at the Office of Administrative Hearings. Petitioner was accorded post- 
termination procedural due process. 

8. Petitioner did not object at the hearing to the legality of Respondent's interpretation of G.S. 

135- 106(b) but only in the manner and procedure employed by Respondent to reduce Petitioner's long term 
disability benefits. 

Based upon the foregoing Findings of Fact and Conclusions of Law. the undersigned makes the 
following: 



* Although the pre-termination notice may be sufficient in law . such a change in the interpretation of the 
controlling statute does not appear to grant sufficient time for the affected class to which Petitioner belonged 
to apply and receive the Social Security retirement benefit to which they were actually entitled. 



2203 7:19 NORTH CAROLINA REGISTER January 4. 1993 



CONTESTED CASE DECISIONS 



RECOMMENDED DECISION 

That the Respondent affirm its decision to reduce Petitioner's long term disability benefit pursuant 
to G.S. 135- 106(b) and that any overpayment resulting to the Petitioner be recouped from the Petitioner as 
provided by law. 

ORDER 

It is hereby ordered that the agency serve a copy of the final decision on the Office of Administrative 
Hearings, P.O. Drawer 27447. Raleigh. N. C. 27611-7447, in accordance with North Carolina General 
Statute 150B-36(b). 

NOTICE 

The agency making the final decision in this contested case is required to give each party an 
opportunity to file exceptions to this recommended decision and to present written arguments to those in the 
agency who will make the final decision. G.S. 150B-36(a). 

The agency is required by G.S. 150B-36(b) to serve a copy of the final decision on all parties and to 
furnish a copy to the parties' attorney of record and to the Office of Administrative Hearings . 

The agency that will make the final decision in this contested case is The Board of Trustees of the 
Teachers' and State Employees' Retirement System. 

This the 7th day of December. 1992 



Julian Mann, III 

Chief Administrative Law Judge 



7:19 NORTH CAROLINA REGISTER January 4, 1993 2204 



CONTESTED CASE DECISIONS 



STATE OF NORTH CAROLINA 



COUNTY OF MECKLENBURG 



IN THE OFFICE OF 
ADMINISTRATIVE HEARINGS 

92 DHR 0853 



BRITTHAVEN. INC. d/b/a BRITTHAVEN OF 
CHARLOTTE. 

Petitioner. 



\ . 



NORTH CAROLINA DEPARTMENT OF HUMAN 
RESOURCES. DIVISION OF FACILITY SERVICES. 
LICENSURE SECTION. 

Respondent. 



RECOMMENDED DECISION 
BASED ON STIPULATED FACTS 



This contested case came on for hearing before the undersigned based upon stipulated facts and 
affidavits submitted by the parties. Petitioner Britthaven. Inc. d, b/a Britthaven of Charlotte (hereinafter 
"Britthaven") and Respondent North Carolina Department of Human Resources. Division of Facility Services. 
Licensure Section (hereinafter "Licensure Section" or the "Agency"). Those stipulations and affidavits have 
previously been filed with this office. 

ISSUES 

1 . Whether the Licensure Section properly and correctly imposed administrative penalties upon 
Britthaven for alleged incidents of failure to provide adequate care, treatment and services to patients. 

2. If so. whether the amounts of the administrative penalties are reasonable. 

JURISDICTION 

1. The parties are properly before the Office of Administrative Hearings, and the Office of 
Administrative Hearings has jurisdiction over the parties and over the subject matter of this contested case 
hearing. 

2. The parties have been correctly designated, and there are no issues as to nonjoinder or 
misjoinder of parties. The parties are not aware of any other person seeking to intervene. 

3. The Administrative Law Judge is properly designated and appointed and that the parties are 
unaware of any reason for which he should be disqualified. 

BURDEN OF PROOF 

The burden of going forward with evidence in the burden of persuasion lie with Respondent. In order 
to prevail. Respondent has the burden to prove by the greater weight of the evidence that it properly and 
correctly imposed administrative penalties upon Petitioner for alleged incidents of failure to provide adequate 
care, treatment and services to patients, and that the amounts of the administrative penalties, if warranted, are 
reasonable. 



2205 



7:19 



NORTH CAROLINA REGISTER 



January- 4, 1993 



CONTESTED CASE DECISIONS 



FINDINGS OF FACTS 

1 . Petitioner Britthaven is a nursing home located in Charlotte. Mecklenburg County, North 
Carolina. 

2. Respondent Licensure Section is the agency empowered pursuant to N.C.G.S. §131 E- 1 29, 
to impose administrative penalties upon nursing homes located in North Carolina. 

3. On August 6, 1991, complaint investigators with the Licensure Section visited Britthaven for 
the purpose of investigating a report of possible deviations from statutes and regulations governing the 
licensure and operation of nursing homes. 

4. Based upon that investigation, complaint investigators made recommendations for 
administrative action with regard to two patients. 

5. The investigators' recommendations were submitted to an Internal Review Committee, 
comprised of three staff members of the Licensure Section, which on December 11, 1991, recommended that 
the Licensure Section assess Britthaven two Type B-2 administrative penalties, in the amount of $50 each, for 
alleged violations based upon their conclusion that while there had been violations of the Nursing Home 
Patients Bill of Rights and applicable regulations, a causal connection could not be established between the 
facility's actions and the patients' conditions. 

6. The Internal Review Committee's recommendation was submitted to the Agency's Penalty 
Review Committee ("PRC") which on January 16, 1992, recommended each penalty be increased to a Type 
A-l $250 penalty, for a total penalty amount of $500. 

7. PRC members voting at the January 16, 1992, meeting to increase in the penalty amount were 
Albert Thompson, David Donovan, Stewart Vick, and Alfred Boyles. PRC members voting against the 
recommendation to increase the penalty were Rebecca Dennis Olson, Gerald Cox and Edward Hart. 

8. On February 10. 1992, the Licensure Section adopted the PRC's recommendation and 
imposed a $500 administrative penalty upon Britthaven by letter from Jesse S. Goodman, Assistant Director, 
Licensure and Certification to Elsie J. Kevas, Administrator, Britthaven of Charlotte. 

9. By letter dated April 22, 1992, Mr. Goodman advised Ms. Kevas that the Licensure Section 
was rescinding the administrative penalty and resubmitting the information regarding the penalty to the PRC 
for consideration at its meeting on May 21, 1992. 

10. On June 18, 1992, the PRC recommended that each penalty be increased to a Type A-l $250 
penalty. 

1 1 . PRC members voting at the June 18. 1992 meeting to increase the penalty amount were Albert 
Thompson. Rebecca Dennis Olson, David Donovan, Gayle Fleming and Alfred Boyles. PRC members voting 
against the recommendation to increase the penalty were Gerald Cox, Edward Hart and Stewart Vick. 

12. Mr. Goodman accepted the June 18. 1992 recommendation of the Penalty Review Committee 
and imposed an administrative penalty in the amount of $500 upon Britthaven by letter to Elsie J. Kevas dated 
June 26. 1992. 

13. Britthaven timely appealed the imposition of the administrative penalty by Petition for 
Contested Case Hearing filed July 23, 1992. 

14. On November 12, 1992, Britthaven filed a Motion for a Recommended Decision in the nature 
of Summary Disposition. On November 30, 1992, Britthaven filed a Motion to Dismiss with regard to the 



7:19 NORTH CAROLINA REGISTER January 4, 1993 2206 



CONTESTED CASE DECISIONS 



second patient for which the agency issued an administrative penalty. Britthaven withdraws those motions. 

Patient #1 ("B.C.") 

15. Patient #1 ("B.C.") was a 79 year old resident who was readmitted to the facility on July 16, 
1991, after an eight-day period of hospitalization where she was treated for bullous pemphigus and congestive 
heart failure. Her hospital diagnoses included: cerebral vascular accident with right hemiplegia, hypertension, 
atrial fibrillation, Brady arrhythmias, renal failure and syphilis (treated). Treatment of the pemphigus with 
Prednisone was continued after readmission to the facility. 

16. On July 18, 1991. B.C.'s condition deteriorated, culminating in her death at 3:40 p.m. The 
course of events were documented in the nurse's notes as follows: 

0600 - A quiet night - respiration rapid - No complaints. Alert and responsive - turned and positioned 
every 2 hours. No request for Oxygen. T96.7-P72-R28-BP 120/70 

10: 15 a.m. - Alert and responsive, color good, skin w/d to touch. Resp. rapid @ 24-26. BP120/70 
P88 T97.4. Patient unable to assist with care. Naps off and on, repositioned every 2 hours and as 
needed. SR Call light within reach. Skin remains very dry. Lotion as order. Lesion dryed 
increased. Spoon fed, ate 100%. Inc of BtBn changes prn. s c/o on S.O.D. noted. 

10:45 a.m. - Patient noted to be dyspenic. Order received for Oxygen at 2 liters/minute prn. 

2:50 p.m. - CNA found patient cold and clammy, had to change patient's entire bed. BP 80/60 T96 
P unable to feel @ etc. R-38 rapid. Patient alert and responsive to stimuli. Dr. Cynn notified 
waiting for return call. 

3:00 p.m. - Tried to contact Dr. Cynn again. Nurse states, "I'm going to beep him." Patient chest 
sounds very congested. Unable to get a pulse. 

3:40 p.m. - LPN found patient with no detectable respiration, no palpable pulse (radial or carotid) 
unable to auscultate BP. CPR started immed. by LPN and RN with board under back. 91 1 called 
by nurse. CPR continued until emergency crew arrived. Family member was called by staff with 
report of patient's condition. Message left with husband of responsible party. Emergency crew 
continued emergency measures were unable to detect any vital signs. Noted dilated pupils. Call 
placed to CMH and permission received to declare patient expiration. 

4:10 p.m. - Attempt to call family members unsuccessful. Call placed to funeral home, they stated 
they knew the family and would make an attempt to locate them. 

4:35 p.m. - Call placed to granddaughter in Wadesboro. Will have responsible party call us back. 

4:10 p.m. - late entry - call placed to Dr. with report of patient's expiration. 

4:45 p.m. - R.D.. patient's sister called and gave permission to release the body to Smith Funeral 
Home, Wadesboro. 

4:50 p.m. - Funeral home was called to pick up body. 

6:30 p.m. - Funeral home came to facility to transport body to Wadesboro, Smith Funeral Home. 

17. In addition to notations made in the nursing notes regarding B.C., additional measures were 
taken to care for this patient on July 18. 1991, between 7:30 a.m. and 3:40 p.m. 

Specifically, the following measures were taken: 



2207 7:19 NORTH CAROLINA REGISTER January 4, 1993 



CONTESTED CASE DECISIONS 



7:30 a.m. Blood pressure, temperature, and other vital signs taken, bed bath; 

8:00 a.m. Spoon feeding breakfast; 
10:00 a.m. Vital signs taken, patient assessed; 
10:35 a.m. Patient repositioned; 
12:00 noon Ampicillin administered; 
12:40 p.m. Vital signs taken, spoon fed lunch; 

1:00 p.m. Niacinamide given and magic mouthwash swish and swallow done; 

2:00 p.m. Vital signs taken; 

2:45 p.m. Vital signs taken; 

3:00 - 3:15 p.m. On-coming charge nurse made routine rounds. 

18. Patient B.C.'s room was only 2 patient rooms from the nurse's station. She was being 
constantly monitored during the entire day on July 18. 1991, prior to her death at 3:40 p.m. 

Patient #2 ("W..T.") 

19. Patient #2 ("W.J.") was an 80 year old male who was readmitted to Britthaven on May 27, 
1991 after a ten day hospitalization at Mercy Hospital in Charlotte including a stay in the Intensive Care Unit. 
He had a history of decompensated congestive heart failure, pulmonary embolus, deep vein thrombosis, and 
while in the hospital on May 18, 1991, he had a respiratory arrest, secondary to hypoxemia and was 
resuscitated. According to the hospital discharge summary, several times in the past W.J. had documented 
pulmonary embolus. 

20. Upon return to Britthaven, W.J. was documented to be alert and oriented. For the next 21/2 
days he remained stable on oxygen at 2 liters per minute, with temperatures 96.4° to 99.4° F, pulses 58 to 
80, respirations 18 to 48. and blood pressures 120/60 to 156/80. He received Lasix 40mg, Digoxin .25mg, 
and Coumadin 5mg every day. 

21. Beginning at 4:00 p.m. on May 30, 1991, patient W.J.'s nurses notes were as follows: 

1600 hrs. - pt. condition remains unchanged, guarded. Oxygen per nasal canal at 2 liters per min. 
in progress. Position turned every 2 hr. Skin warm and dry: responsive to stimuli. Digs. P. 
0.:intake poor, unable to swallow on his own. Right side of mouth twisted, BP124/16. P64, R22, 
temp. 99.4. 

2100 hrs. - Pt. unresponsive. Vital signs remains stable, BP/I 14/70, P. 60. R. 16 Unable to consume 
diet self. Not swallowing. Food holding in his mouth. Mouth care given by staff and feedings by 
staff. 

2315 hrs. - Condition unchanged. Remains guarded. Oxygen via nasal cannule at 2 liters/minute. 
Skin cool and moist to touch. Respirations shallow. 

2400 hrs. - No changes noted, respirations remain shallow. 

5/31/91 

0040 hrs. - Patient found unresponsive. Night charge nurse was called. Vital signs were taken. 

None present. Dr. Richardson's answering service was called by RN on duty. 

0100 hrs. - No call received from Dr. Richardson. Answering service called again. 

0110 hrs. - Dr. Richardson returned call. Stated her answering service did not contact her previously 
(at 0040). Asked for orders. Dr. Richardson suggested I call the DON and ask for facility procedure 
and act accordingly. DON notified of situation. Suggestion made to send pt. to hospital ER to be 
pronounced. Dr. Richardson notified of this. Stated that she would sign death certificate in A.M. 
911 called. CPR initiated. Paramedic and 911 responded. Carried out necessary procedures for 



7:79 NORTH CAROLINA REGISTER Januan' 4, 1993 2208 



CONTESTED CASE DECISIONS 



present situation. 

0230 hrs. - Family was notified and changed funeral home to Beasley's. 

0400 hrs. - Body released to Beasley's Funeral Home. 

22. On May 30, 1991, at 11:00 p. m., Edith Williams, R.N., the nurse in charge of the 11:00 
p.m. to 7:00 a.m. shift, reviewed the condition of the patients with Loretta O'Malley, the nurse in charge of 
the 3:00 p.m. to 1 1 :00 p.m. shift. 

23. As they conducted their shift rounds, Ms. O'Malley specifically pointed out to Ms. Williams 
the condition of patient W.J. in room 24-A. They observed W.J. carefully because Ms. O'Malley felt that 
he was the sickest patient in the building on that evening. When they visited him in his room, his respirations 
were regular and appeared unlabored, and his pulse was strong and regular. His extremities were cool to the 
touch but they had been so for a number of days. Basically, his condition appeared to Ms. Williams to be 
the same as on previous evenings since he returned from the hospital. Ms. O'Malley stated that his condition 
appeared to be unchanged since she had last monitored him at 10:00 p.m. 

24. After they completed their shift rounds, Ms. Williams began to monitor and assess other 
patients in the SNF wing, who were also in critical condition. She received no further information regarding 
W.J.'s condition until some time after 12:40 a.m.. at which time. Mary Caldwell, L.P.N.. advised her that 
during a monitoring visit W.J. had no respiration or pulse. 

25. W.J. had been seriously ill for some period of time. He had been in and out of the hospital 
several times during the months prior to his expiration. 

26. Respondent's nurse consultants contacted the North Carolina Board of Nursing for 
investigation regarding their findings. 

27. With regard to patient W.J., the North Carolina Board of Nursing issued a reprimand to Mary 
Caldwell, L.P.N., for failure to initiate resuscitative measures when she found him to be without respirations 
or heartbeat. The Board of Nursing determined that no action should be taken against Edith Williams, R.N., 
the supervisor R.N. on that shift, or any other nurse, with regard to the care of patient W.J. No citations 
were made by the Board of Nursing regarding patient B.C., or regarding nursing assessment of either patient. 

28. The Agency's internal guidelines define a Type A-l violation as "[o]ne violation involving 
one patient with substantial risk of death or serious physical harm." 

29. Agency internal guidelines define a Type B-2 violation as "[o]ne violation invoking one or 
more patients put at risk with minimal or potential impact on patient health, safety or welfare." 

30. With the exception of the administrative penalty which is the subject of this contested case, 
the Agency has noted no violations of licensure statutes or rules at the Britthaven facility warranting an 
administrative penalty or other negative sanctions. 

31. Following receipt of the Agency's Report of Survey dated September 13. 1991 , reporting on 
the August 6, 1991. complaint investigation, Britthaven submitted a Plan of Correction to the Agency on 
September 30, 1991, providing that all deficiencies noted would be adequately addressed and corrected by 
October 11. 1991 . The Agency accepted that Plan of Correction and requested no changes, and the Agency 
has not cited Britthaven for failing to timely implement that Plan of Correction. 

Based upon the foregoing Findings of Fact, the undersigned makes the following: 



2209 7:19 NORTH CAROLINA REGISTER January 4, 1993 



CONTESTED CASE DECISIONS 



CONCLUSIONS OF LAW 

1. A Type A violation is defined by G.S. §131E-129(a)(l) as 

a violation by a facility of the regulations, standards, and requirements set forth in G.S. 
13IE-117. or applicable State or federal laws and regulations governing the licensure or 
certification of a facility which creates substantial risk that death or serious physical harm to 
a resident will occur or where such harm has occurred. 

2. A Type B violation is defined in G.S. § 1 3 1 E- 129(a)(2) as 

a violation by a facility of the regulations, standards, and requirements set forth in G.S. 
131 E- 117, or applicable State or federal laws and regulations governing the licensure or 
certification of a facility which presents a direct relationship to the health, safety or welfare 
of any resident, but which does not create substantial risk that death or serious physical harm 
will occur. 

3. In determining the amount of the penalty, G.S. §13 1E-1 29(c) sets forth the following factors 
which must be considered by the Agency: 

(1 ) The gravity of the violation, including the probability that death or serious physical 
harm to a resident will result or has resulted; the severity of the actual or potential 
harm, and the extent to which the provisions of the applicable statutes or regulations 
were violated; 

(2) The reasonable diligence exercised by the licensee and efforts to correct violations; 

(3) The number and type of previous violations committed by the licensee; 

(4) The amount of assessment necessary to ensure immediate and continued compliance; 
and 

(5) The number of patients put at risk by the violation. 

4. Based upon the foregoing definitions, and the Agency's own internal guidelines set forth in 
Finding of Fact numbers 28 and 29, the Agency has failed to sustain its burden of showing that the actions 
of Britthaven created a substantial risk that death or serious physical harm would occur to patients B.C. or 
W.J., or that such harm occurred. Therefore, the Agency has failed to sustain its burden that a Type A 
violation was justified. 

5. The Agency has sustained its burden of showing that the actions of Britthaven constituted a 
violation of the regulations, standards and requirements set forth in G.S. 131 E- 117 or applicable state or 
federal laws and regulations, which presented a direct relationship to the health, safety, or welfare of patients 
B.C. and W.J., but which did not create substantial risk that death or serious physical harm would occur to 
those patients. Therefore, the Agency has sustained its burden of showing that it properly and correctly 
imposed administrative penalties upon Britthaven for failure to provide adequate care, treatment and services 
to patients. 

6. The Agency's Internal Review Committee's conclusion that the alleged violations by 
Britthaven warranted two Type B-2 $50 penalties was a reasonable penalty amount which should have been 
imposed. 



7:19 NORTH CAROLINA REGISTER January 4, 1993 2210 



CONTESTED CASE DECISIONS 



RECOMMENDED DECISION 

Based upon the foregoing Findings of Fact and Conclusions of Law, it is recommended that the final 
decision maker order that the administrative penalty imposed by the Licensure Section upon Britthaven be 
reduced to two Type B-2 $50 penalties, for a total penalty amount of $100. 

NOTICE 

The Agency making the final decision in this contested case is required to give each party the 
opportunity to file exceptions to this recommended decision and to present written arguments to those in the 
Agency who will make the final decision. G.S. $ 150B-36(a). The Agency that will make the final decision 
in this contested case is the North Carolina Department of Human Resources. 

This the 9th day of December, 1992. 



i 



Fred G. Morrison. Jr. 
Administrative Law Judge 



I 



2211 7:19 NORTH CAROLINA REGISTER January 4, 1993 



NORTH CAROLINA ADMINISTRATIVE CODE CLASSIFICATION SYSTEM 



1 he North Carolina Administrative Code (NCAC) has four major subdivisions of rules. Two of these, 
titles and chapters, are mandatory. Tfie major subdivision of the NCAC is the title. Each major 
department in the North Carolina executive branch of government has been assigned a title number. 
Titles are further broken down into chapters which shall be numerical in order. Tlie other two. 
subchapters and sections are optional subdivisions to be used by agencies when appropriate. 



TITLE/MAJOR DIVISIONS OF THE NORTH CAROLINA ADMINISTRATIVE CODE 
TITLE DEPARTMENT LICENSING BOARDS CHAPTER 



1 


Administration 




Architecture 




2 


2 


Agriculture 




Auctioneers 




4 


3 


Auditor 




Barber Examiners 




6 


4 


Economic & Community Development 


Certified Public Accountant Examiners 


8 


5 


Correction 




Chiropractic Examiners 




10 


6 


Council of State 




General Contractors 




12 


7 


Cultural Resources 




Cosmetic Art Examiners 




14 


8 


Elections 




Dental Examiners 




16 


9 


Governor 




Dietetics/Nutrition 




17 


III 


Human Resources 




Electrical Contractors 




IS 


II 


Insurance 




Electrolysis 




19 


12 


Justice 




Foresters 




20 


13 


Labor 




Geologists 




21 


14A 


Crime Control & Public 


Safety 


Hearing Aid Dealers and Fitters 




22 


15A 


Environment, Health, and Natural 


Landscape Architects 




26 




Resources 




Landscape Contractors 




28 


16 


Public Education 




Marital and Family Therapy 




51 


17 


Revenue 




Medical Examiners 




32 


18 


Secretary of State 




Midwifery Joint Committee 




33 


19A 


Transportation 




Mortuary Science 




34 


20 


Treasurer 




Nursing 




36 


♦21 


Occupational Licensing 


Boards 


Nursing Home Administrators 




37 


22 


Administrative Procedures 


Occupational Therapists 




38 


23 


Community Colleges 




Opticians 




40 


24 


Independent Agencies 




Optometry 




42 


25 


State Personnel 




Osteopathic Examination & Reg. 


(Repealed) 


44 


26 


Administrative Hearings 




Pharmacy 

Physical Therapy Examiners 




46 

4S 








Plumbing, Heating & Fire Sprinkler Contractors 


50 








Podiatry Examiners 




52 








Practicing Counselors 




53 








Practicing Psychologists 




54 








Professional Engineers & Land Surveyors 


56 








Real Estate Commission 




58 








Refrigeration Examiners 




60 








Sanitarian Examiners 




62 








Social Work 




63 








Speech & Language Pathologists 


& Audiologists 


64 








Veterinary Medical Board 




66 



Note: Title 21 contains the chapters of the various occupational licensing boards. 



7:19 



NORTH CAROLINA REGISTER 



January 4, 1993 



2212 



CUMULATIVE INDEX 



CUMULATIVE INDEX 

(April 1992 - March 1993) 



Pages 



Issue 



1 - 105 1 April 

106 - 173 2 April 

174 - 331 3 May 

332 - 400 4 - May 

401 - 490 5 - June 

491 - 625 6 - June 

626 - 790 7 - July 

791 - 902 8 - July 

903 - 965 9 - August 

966 - 1086 10 - August 

1087 - 1 154 11 September 

1 155 - 1253 12 September 

1254-1350 13 October 

1351 - 1463 14 October 

1464 - 1640 15 November 

1641 - 1720 16 - November 

1721 - 1828 17 - December 

1829 - 2059 18 December 

2060 - 2215 19 - January 

ADMINISTRATION 

Auxiliary Services. 4 

Motor Fleet Management Division. 794 

AGRICULTURE 

Gasoline and Oil Inspection Board. 336 

Pesticide Board. 1276 

Plant Industry. 904 

Structural Pest Control Committee, 332 

Veterinary Division. 342 

COMMUNITY COLLEGES 

Community Colleges. 1535 
General Provisions. 1531 
Miscellaneous Programs, 1598 

CULTURAL RESOURCES 

U.S.S. Battleship Commission, 911 

ECONOMIC AND COMMUNITY DEVELOPMENT 

Banking Commission, 629. 1467 
Community Assistance, 909. 968 
Departmental Rules, 801 
Savings Institutions Division. 1833 

ENVIRONMENT. HEALTH. AND NATURAL RESOURCES 

Adult Health. 1199 

Coastal Management, 211, 655. 1098. 1507 
Departmental Rules. 826. 1852 
Environmental Health. 223 



2213 



7:19 



XORTH CAROLINA REGISTER 



January 4, 1993 



CUMULATIVE INDEX 



Environmental Management, 190, 416, 500, 644, 830, 1013, 1487, 1856, 2086 

Governor's Waste Management Board, 564, 920, 1 197 

Health: Epidemiology, 140, 1212 

Health: Personal Health, 1217 

Health Services, 52, 659, 1174, 1736, 1985, 2141 

Marine Fisheries, 530 

NPDES Permits Notices, 1, 107 

Radiation Protection, 136, 1520, 1863, 2087 

Sedimentation Control, 920 

Vital Records, 565 

Wildlife Resources Commission, 28, 133, 408, 449, 551, 921, 1299. 1414, 1658, 1736 

Wildlife Resources Commission Proclamation, 176, 2082 

FINAL DECISION LETTERS 

Voting Rights Act, 106, 174, 406, 493, 628, 793, 966, 1090, 1275, 1465, 1644, 1721 

GENERAL STATUTES 

Chapter 150B, 1254, 2060 

GOVERNOR/LT. GOVERNOR 

Executive Orders, 401, 491, 626, 791, 903, 1087, 1155, 1351, 1464. 1641, 1829, 2081 

HUMAN RESOURCES 

Aging, Division of, 121, 346 

Day Care Rules, 123 

Economic Opportunity, 5 

Facility Services, 111, 177, 496, 634, 980, 1352, 1647 

Medical Assistance, 4, 415, 496, 816, 989, 1156, 1295. 1391, 1649, 1723, 1842, 2083 

Mental Health, Developmental Disabilities and Substance Abuse Services, 111, 297, 409, 809, 1092, 1276 

Social Services Commission, 183, 911, 1471 

INDEPENDENT AGENCIES 

Housing Finance Agency, 450, 576, 928, 1219 
Safety and Health Review Board, 2190 

INSURANCE 

Actuarial Services Division, 1411 

Agent Services Division, 1410 

Consumer Services Division, 125, 1157 

Departmental Rules, 7, 1095, 1405 

Engineering and Building Codes, 19, 643 

Financial Evaluation Division, 1162, 1849 

Fire and Rescue Services Division, 17. 1406 

Hearings Division, 124, 1096 

Life and Health Division. 22, 347, 1167 

Market Conduct Division, 1850 

Medical Database Commission. 1650 

Property and Casualty Division, 20, 1848 

Seniors' Health Insurance Information Program, 132 

JUSTICE 

Alarm Systems Licensing Board, 27, 189, 643, 919, 1414, 1486. 1732 
Criminal Information, 1097 
General Statutes Commission, 353 
Private Protective Services, 918, 1731 



7:19 NORTH CAROLINA REGISTER January 4, 1993 2214 



CUMULATIVE INDEX 



Sheriffs Education and Training. 990 

State Bureau of Investigation. 188, 499. 1413 

LICENSING BOARDS 

Architecture. 1111 

Certified Public Accountant Examiners. 355 

Chiropractic Examiners. 1416 

Cosmetic Art Examiners. 360, 922. 1669 

Dietetics/Nutrition. 923 

Electrical Contractors. 1785 

Electrolysis Examiners, 69. 700 

Geologists, 1792 

Medical Examiners, 1304. 1417. 1987 

Mortuary Science, Board of, 2184 

Nursing. Board of. 232. 700. 1528 

Opticians. 1793 

Pharmacy. Board of. 1418 

Professional Engineers and Land Surveyors, 566 

Speech and Language and Pathologists and Audiologists, 705 



i 



LIST OF RULES CODIFIED 

List of Rules Codified, 72, 362, 452. 584, 



1671 



PUBLIC EDUCATION 

Departmental Rules. 1 108 

Elementary' and Secondary. 852. 1108. 1666 

REVENUE 

License and Excise Tax. 712 
Motor Fuels Tax, 361 

STATE PERSONNEL 

Office of State Personnel. 237. 705. 1113. 1419. 2005 

TAX REVIEW BOARD 

Orders of Tax Review. 494 

TRANSPORTATION 

Highways. Division of. 228. 856. 1062. 1110. 1669. 1781 
Motor Vehicles, Division of. 68, 142 



( 



2215 



7:19 



NORTH CAROLINA REGISTER 



Januan' 4, 1993 



NORTH CAROLINA ADMINISTRATIVE CODE 



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